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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Evidence review for antibiotics for bacterial meningitis caused by Haemophilus influenzae - NCBI Bookshelf</title>
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caused by Haemophilus influenzae" /></a></div><div class="bkr_bib"><h1 id="_NBK604078_"><span itemprop="name">Evidence review for antibiotics for bacterial meningitis caused by Haemophilus influenzae</span></h1><div class="subtitle">Meningitis (bacterial) and meningococcal disease: recognition, diagnosis and management</div><p><b>Evidence review E2</b></p><p><i>NICE Guideline, No. 240</i></p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2024 Mar</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5766-8</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2024.</div></div><div class="bkr_clear"></div></div><div id="niceng240er16.s1"><h2 id="_niceng240er16_s1_">Antibiotics for bacterial meningitis caused by Haemophilus influenzae</h2><div id="niceng240er16.s1.1"><h3>Review question</h3><p>What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</p><div id="niceng240er16.s1.1.1"><h4>Introduction</h4><p>Bacterial meningitis is a rare but serious infection. The causative organism is usually confirmed by tests performed on cerebrospinal fluid or blood samples. Haemophilus influenzae is now a very rare cause of bacterial meningitis in the UK due to the success of the childhood vaccination programme.</p><p>The aim of this review is to determine what antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae.</p></div><div id="niceng240er16.s1.1.2"><h4>Summary of the protocol</h4><p>See <a href="/books/NBK604078/table/niceng240er16.tab1/?report=objectonly" target="object" rid-ob="figobniceng240er16tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng240er16tab1"><a href="/books/NBK604078/table/niceng240er16.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img" rid-ob="figobniceng240er16tab1"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng240er16.tab1"><a href="/books/NBK604078/table/niceng240er16.tab1/?report=objectonly" target="object" rid-ob="figobniceng240er16tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol (PICO table). </p></div></div><p>For further details see the review protocol in <a href="#niceng240er16.appa">appendix A</a>.</p></div><div id="niceng240er16.s1.1.3"><h4>Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng240er16.appa">appendix A</a> and the <a href="/books/NBK604078/bin/NG240-Methods-pdf.pdf">methods</a> document (supplementary document 1).</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng240er16.s1.1.4"><h4>Effectiveness evidence</h4><div id="niceng240er16.s1.1.4.1"><h5>Included studies</h5><p>Two studies were included for this review: 1 retrospective cohort study (<a class="bibr" href="#niceng240er16.s1.ref1" rid="niceng240er16.s1.ref1">Lapointe 1988</a>), and 1 randomised controlled trial (RCT: <a class="bibr" href="#niceng240er16.s1.ref2" rid="niceng240er16.s1.ref2">Molyneux 2011</a>).</p><p>The included studies are summarised in <a href="/books/NBK604078/table/niceng240er16.tab2/?report=objectonly" target="object" rid-ob="figobniceng240er16tab2">Table 2</a>.</p><p>One study compared cefotaxime to chloramphenicol (<a class="bibr" href="#niceng240er16.s1.ref1" rid="niceng240er16.s1.ref1">Lapointe 1988</a>) and did not adjust for confounding factors. One study compared 5-day ceftriaxone therapy to 10-day ceftriaxone therapy (<a class="bibr" href="#niceng240er16.s1.ref2" rid="niceng240er16.s1.ref2">Molyneux 2011</a>). All studies were conducted in babies and children (<a class="bibr" href="#niceng240er16.s1.ref1" rid="niceng240er16.s1.ref1">Lapointe 1988</a>; <a class="bibr" href="#niceng240er16.s1.ref2" rid="niceng240er16.s1.ref2">Molyneux 2011</a>).</p><p>See the literature search strategy in <a href="#niceng240er16.appb">appendix B</a> and study selection flow chart in <a href="#niceng240er16.appc">appendix C</a>.</p></div><div id="niceng240er16.s1.1.4.2"><h5>Excluded studies</h5><p>Studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng240er16.appj">appendix J</a>.</p></div></div><div id="niceng240er16.s1.1.5"><h4>Summary of included studies</h4><p>Summaries of the studies that were included in this review are presented in <a href="/books/NBK604078/table/niceng240er16.tab2/?report=objectonly" target="object" rid-ob="figobniceng240er16tab2">Table 2</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng240er16tab2"><a href="/books/NBK604078/table/niceng240er16.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img" rid-ob="figobniceng240er16tab2"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng240er16.tab2"><a href="/books/NBK604078/table/niceng240er16.tab2/?report=objectonly" target="object" rid-ob="figobniceng240er16tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of included studies. </p></div></div><p>See the full evidence tables in <a href="#niceng240er16.appd">appendix D</a>. No meta-analysis was conducted (and so there are no forest plots in <a href="#niceng240er16.appe">appendix E</a>).</p></div><div id="niceng240er16.s1.1.6"><h4>Summary of the evidence</h4><p>This section is a narrative summary of the findings of the review, as presented in the GRADE tables in <a href="#niceng240er16.appf">appendix F</a>. For details of the committee’s confidence in the evidence and how this affected recommendations, see <a href="#niceng240er16.s1.1.9">The committee’s discussion and interpretation of the evidence</a>.</p><p>The evidence was assessed as being very low quality due to risk of bias (arising from missing outcome data due to attrition, subjective measurement of the outcome, selective reporting, and failure to adjust for confounding factors), seriously imprecise findings and the inclusion of indirect populations and outcomes.</p><p>No important difference in mortality was shown between cefotaxime and chloramphenicol in the evidence reviewed, although cefotaxime was associated with a lower rate of neurological impairment.</p><p>The evidence showed no important differences between 5-day and 10-day ceftriaxone treatment for all-cause mortality, neurological impairment, developmental delay, hearing impairment, serious intervention-related adverse effects, or cerebrospinal fluid (CSF) sterilisation.</p><p>No eligible studies were identified that reported on functional impairment, or intracranial collections as a complication.</p><p>See <a href="#niceng240er16.appf">appendix F</a> for full GRADE tables.</p></div><div id="niceng240er16.s1.1.7"><h4>Economic evidence</h4><div id="niceng240er16.s1.1.7.1"><h5>Included studies</h5><p>A single economic search was undertaken for all topics included in the scope of this guideline, but no economic studies were identified which were applicable to this review question.</p></div></div><div id="niceng240er16.s1.1.8"><h4>Economic model</h4><p>No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.</p></div><div id="niceng240er16.s1.1.9"><h4>The committee’s discussion and interpretation of the evidence</h4><div id="niceng240er16.s1.1.9.1"><h5>The outcomes that matter most</h5><p>Bacterial meningitis is associated with high rates of mortality and morbidity, and antibiotics are the mainstay of treatment for bacterial meningitis. Therefore, all-cause mortality and long-term neurological impairment were prioritised as critical outcomes due to the severity of these outcomes. Severe developmental delay was prioritised over functional impairment in children and babies, as it is a more relevant and important outcome for this population. Functional impairment was prioritised as a critical outcome in adults due to the concern about the potential long-term limitations of bacterial meningitis on the ability to carry out certain activities of daily life.</p><p>In addition to functional impairment (in children and babies), hearing impairment, serious intervention-related adverse effects and CSF sterilisation were selected as important outcomes in all age groups as these are relatively common after bacterial meningitis and may be related to antibiotic therapy. Intracranial collections as a complication was also included as an important outcome for adults as this is a rare but severe and life threatening complication of bacterial meningitis that may require prolonged antibiotic treatment.</p></div><div id="niceng240er16.s1.1.9.2"><h5>The quality of the evidence</h5><p>The quality of the evidence was assessed using GRADE methodology. The evidence for all outcomes in this review was very low quality, and the main reasons for downgrading the evidence were risk of bias (arising from missing outcome data, subjective measurement of the outcome, selective reporting, and failure to adjust for confounding factors), imprecision (due to wide confidence intervals and small number of events), and indirectness (of either population, outcome, or both).</p><p>No evidence was found for functional impairment, or intracranial collections as a complication.</p></div><div id="niceng240er16.s1.1.9.3"><h5>Benefits and harms</h5><p>The committee considered the evidence comparing cefotaxime and chloramphenicol for the treatment of meningitis caused by Haemophilus influenzae type b (Hib), that showed no important difference for mortality, but a lower rate of long-term neurological impairment associated with cefotaxime. However, the committee noted that this evidence came from a retrospective cohort study with a small sample size. No other evidence was identified comparing the effectiveness of different antibiotics for the treatment of Hib meningitis. Given the limitations of the evidence, the committee agreed to make recommendations based on their clinical knowledge and experience, and on current practice, and recommended ceftriaxone in line with the BNF (<a class="bibr" href="#niceng240er16.s1.ref4" rid="niceng240er16.s1.ref4">Joint Formulary Committee 2022</a>) and BNFC (<a class="bibr" href="#niceng240er16.s1.ref6" rid="niceng240er16.s1.ref6">Paediatric Formulary Committee 2022</a>), for the treatment of Hib meningitis. The committee were aware that insufficient dose can increase the risk of treatment failure and antibiotic resistance; therefore, they agreed to use the maximum dose recommended by the BNF or BNFC or follow local antimicrobial guidance.</p><p>The committee highlighted the potential practical and resource-use advantages associated with ceftriaxone because the long half-life means that it can be given only once a day. The committee acknowledged some concerns with once daily administration in that a second dose might need to be delayed if the first dose of ceftriaxone was administered outside of routine working hours; however, they were aware that a second dose can be given earlier, to shift the administration time, if there is a minimum of 12 hours between doses (<a class="bibr" href="#niceng240er16.s1.ref3" rid="niceng240er16.s1.ref3">Gbesemete 2019</a>).</p><p>The committee discussed some reasons why in clinical practice (particularly in intensive care units) cefotaxime might be given instead of ceftriaxone. For instance, to minimise the time that intravenous lines are being used for administering antibiotics, which might be needed for other medications, due to ceftriaxone typically being infused over 30 minutes intravenous and cefotaxime being given as a bolus. However, the committee agreed that this practice is not necessary, as ceftriaxone can be given as bolus. Sometimes there may be a reaction (for example, vomit reflex) if ceftriaxone is administered too quickly, but in the committee’s experience this is relatively rare, which was supported by a recent study (<a class="bibr" href="#niceng240er16.s1.ref7" rid="niceng240er16.s1.ref7">Patel 2021</a>). The committee agreed that ceftriaxone should be given as first-line treatment for Hib meningitis, unless contraindicated in which case cefotaxime can be considered.</p><p>The committee agreed that advice from an infection specialist (a microbiologist or infectious diseases specialist) should be sought, given that Hib infection is now extremely rare in the UK due to vaccination.</p><p>The committee were aware that the previous NICE guideline on meningitis (<a class="bibr" href="#niceng240er16.s1.ref5" rid="niceng240er16.s1.ref5">NICE 2010</a>) recommended 10-day antibiotic treatment for Hib meningitis. However, the committee noted that the evidence reviewed showed no important difference between 5 and 10 days of ceftriaxone therapy, although this study was unlikely to have been adequately powered to be taken as definitive evidence of equivalence. The committee acknowledged that practice has changed since the previous NICE guideline, and that the previous recommendations were consensus rather than evidence based and pre-dated the widespread use of cephalosporins. The committee discussed that, in some instances, practice has moved to shorter (7-day) courses of antibiotics for the treatment of Hib meningitis without apparent impact on clinical outcomes, although they acknowledged that there is variation in practice. The committee were also aware of evidence from low- and middle-income countries, suggesting that shorter length of treatment may be effective. The committee recommended that people with meningitis caused by Hib should be treated for 7-10 days with ceftriaxone (or cefotaxime if ceftriaxone contraindicated). The committee agreed that recommending a range of 7 to 10 days provided flexibility to stop at 7 days if the person had recovered or continue for 10 days if they had not. The committee agreed that further advice from an infection specialist should be sought if patients have not recovered after 10 days.</p><p>There was no evidence found on antibiotic use for Hib meningitis in people with an antibiotic allergy, but the committee agreed it was important to make a recommendation for this population. Based on their knowledge and experience, the committee agreed that cephalosporin-induced anaphylaxis is rare, and the risk-benefit balance of a cephalosporin (relative to chloramphenicol as an alternative) is favourable in most patients with non-severe allergy. Therefore, the committee agreed that clinicians should seek information about the nature of the allergy and advice from an infection specialist before making a treatment decision, particularly for people who are pregnant. The committee acknowledged that it is important that treatment is not delayed; however, they agreed that information about the nature of allergy is often readily available from the patient’s family. The committee agreed that a cephalosporin should still be considered if the nature of the allergic reaction they get is not severe, in accordance with the first line treatment recommended above. However, if the allergic reaction is severe, alternatives to ceftriaxone or cefotaxime will be needed. The committee discussed that chloramphenicol is commonly used in the case of severe beta-lactam (penicillin, amoxicillin, or cephalosporin) allergy. Based on clinical knowledge and experience, the committee recommended chloramphenicol for Hib meningitis and severe antibiotic allergy.</p><p>The committee were aware that the previous NICE guideline on bacterial meningitis (<a class="bibr" href="#niceng240er16.s1.ref5" rid="niceng240er16.s1.ref5">NICE 2010</a>) recommended to treat people who have travelled outside the UK with vancomycin (in addition to the cephalosporin). However, they discussed that practice has changed since the previous NICE guideline. The committee were aware that current practice is to use rifampicin or linezolid in addition to a cephalosporin where the cephalosporin itself might be insufficient due to resistance. However, the committee highlighted that there is not enough evidence to support recommending them. Therefore, the committee recommended that clinicians should seek advice from an infection specialist for all cases of bacterial meningitis, but this was particularly important if cephalosporin resistance is suspected in people who have recently travelled abroad.</p></div><div id="niceng240er16.s1.1.9.4"><h5>Cost effectiveness and resource use</h5><p>This review question was not prioritised for economic analysis and therefore the committee made a qualitative assessment of the likely cost-effectiveness of their recommendations. The committee considered that it would be cost-effective to facilitate the option of a shorter course of antibiotics than in previous NICE guidance (<a class="bibr" href="#niceng240er16.s1.ref5" rid="niceng240er16.s1.ref5">NICE 2010</a>) for meningitis caused by Hib as some practice has moved in this direction without any apparent adverse impact on clinical outcomes. However, given the limitations of the evidence supporting shorter courses they did not want to mandate this, especially as they reasoned that the resource and antibiotic resistance implications of 3 days extra treatment would be minimal. The committee believed that by facilitating the option of a shorter course of antibiotics that their recommendation could lead to some small cost savings for the NHS.</p></div></div><div id="niceng240er16.s1.1.10"><h4>Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.6.4, 1.6.11, and 1.6.16. Other evidence supporting the recommendations 1.6.4 and 1.6.16 can be found in evidence reviews on antibiotic regimens for bacterial meningitis before or in the absence of identifying causative infecting organism (see evidence reviews D1 to D3) and for specific causative organisms (see evidence reviews E1 and E3 to E6).</p></div></div><div id="niceng240er16.s1.rl.r1"><h3>References – included studies</h3><ul class="simple-list"><div id="niceng240er16.s1.rl.r1.1"><h4>Effectiveness</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref1"><p id="p-101">
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<strong>Lapointe 1988</strong>
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</p>Lapointe, J. R. and Chicoine, L. (1988) Cefotaxime versus chloramphenicol for ampicillin-resistant Haemophilus influenzae meningitis. A retrospective study of 62 cases. Drugs
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35suppl2: 199–202
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3260853" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3260853</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref2"><p id="p-102">
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<strong>Molyneux 2011</strong>
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</p>Molyneux, Elizabeth, Nizami, Shaikh Qamaruddin, Saha, Samir
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et al. (2011) 5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study. Lancet (London, England) 377(9780): 1837–45
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[<a href="https://pubmed.ncbi.nlm.nih.gov/21620467" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 21620467</span></a>]</div></p></li></ul></div><div id="niceng240er16.s1.rl.r1.2"><h4>Economic</h4><ul class="simple-list"><p>No studies were identified which were applicable to this review question.</p></ul></div><div id="niceng240er16.s1.rl.r1.3"><h4>Other</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref3"><p id="p-104">
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<strong>Gbesemete 2019</strong>
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</p>Gbesemete, D., Faust, S. (2019). Prescribing in infection: antibacterials. In. Barker, C., Turner, M., Sharland, M. (Eds.) Prescribing Medicines for Children: From drug development to practical administration, Pharmaceutical Press, London: UK</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref4"><p id="p-105">
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<strong>Joint Formulary Committee 2022</strong>
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</p>Joint Formulary Committee. British National Formulary (online). London: BMJ Group and Pharmaceutical Press. Available at: <a href="http://www.medicinescomplete.com" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.medicinescomplete.com</a> [Accessed 04/04/2022]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref5"><p id="p-106">
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<strong>NICE 2010</strong>
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</p>National Institute for Health and Care Excellence (2010). Meningitis (bacterial) and meningococcal septicaemia in under 16s: recognition, diagnosis and management. Available at: <a href="https://www.nice.org.uk/guidance/cg102" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.nice.org.uk/guidance/cg102</a> [Accessed 04/04/2022] [<a href="https://pubmed.ncbi.nlm.nih.gov/32207890" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32207890</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref6"><p id="p-107">
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<strong>Paediatric Formulary Committee 2022</strong>
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</p>Paediatric Formulary Committee. BNF for Children (online). London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Available at: <a href="http://www.medicinescomplete.com" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.medicinescomplete.com</a> [Accessed 29/03/2022]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng240er16.s1.ref7"><p id="p-108">
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<strong>Patel 2021</strong>
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</p>Patel, S., Green. H., Gray, J., Rutter, M., Bevan, A., Hand, K., Jones, C. E., Faust, S. N. (2021). Evaluating Ceftriaxone 80 mg/kg Administration by Rapid Intravenous Infusion—A Clinical Service Evaluation. The Pediatric Infectious Disease Journal, 40(2), 128–129
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[<a href="https://pubmed.ncbi.nlm.nih.gov/33165272" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 33165272</span></a>]</div></p></li></ul></div></ul></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng240er16.appa"><h3>Appendix A. Review protocols</h3><p id="niceng240er16.appa.et1"><a href="/books/NBK604078/bin/niceng240er16-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 262K)</span></p></div><div id="niceng240er16.appb"><h3>Appendix B. Literature search strategies</h3><p id="niceng240er16.appb.et1"><a href="/books/NBK604078/bin/niceng240er16-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Literature search strategies for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 220K)</span></p></div><div id="niceng240er16.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng240er16.appc.et1"><a href="/books/NBK604078/bin/niceng240er16-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 201K)</span></p></div><div id="niceng240er16.appd"><h3>Appendix D. Evidence tables</h3><p id="niceng240er16.appd.et1"><a href="/books/NBK604078/bin/niceng240er16-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Evidence tables for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 206K)</span></p></div><div id="niceng240er16.appe"><h3>Appendix E. Forest plots</h3><div id="niceng240er16.appe.s1"><h4>Forest plots for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</h4><p>No meta-analysis was conducted for this review question and so there are no forest plots.</p></div></div><div id="niceng240er16.appf"><h3>Appendix F. GRADE tables</h3><p id="niceng240er16.appf.et1"><a href="/books/NBK604078/bin/niceng240er16-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">GRADE tables for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 167K)</span></p></div><div id="niceng240er16.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng240er16.appg.et1"><a href="/books/NBK604078/bin/niceng240er16-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</a><span class="small"> (PDF, 106K)</span></p></div><div id="niceng240er16.apph"><h3>Appendix H. Economic evidence tables</h3><div id="niceng240er16.apph.s1"><h4>Economic evidence tables for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</h4><p>No evidence was identified which was applicable to this review question</p></div></div><div id="niceng240er16.appi"><h3>Appendix I. Economic model</h3><div id="niceng240er16.appi.s1"><h4>Economic model for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</h4><p>No economic analysis was conducted for this review question.</p></div></div><div id="niceng240er16.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng240er16.appj.s1"><h4>Excluded studies for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</h4></div><div id="niceng240er16.appj.s2"><h4>Excluded effectiveness studies</h4><p>The excluded studies table only lists the studies that were considered and then excluded at the full-text stage for this review (N=9) and not studies (N=181) that were considered and then excluded from the search at the full-text stage as per the PRISMA diagram in <a href="#niceng240er16.appc">Appendix C</a> for the other review questions in the same search.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng240er16appjtab1"><a href="/books/NBK604078/table/niceng240er16.appj.tab1/?report=objectonly" target="object" title="Table 7" class="img_link icnblk_img" rid-ob="figobniceng240er16appjtab1"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="niceng240er16.appj.tab1"><a href="/books/NBK604078/table/niceng240er16.appj.tab1/?report=objectonly" target="object" rid-ob="figobniceng240er16appjtab1">Table 7</a></h4><p class="float-caption no_bottom_margin">Excluded studies and reasons for their exclusion. </p></div></div></div><div id="niceng240er16.appj.s3"><h4>Excluded economic studies</h4><p>No studies were identified which were applicable to this review question.</p></div></div><div id="niceng240er16.appk"><h3>Appendix K. Research recommendations – full details</h3><div id="niceng240er16.appk.s1"><h4>Research recommendations for review question: What antibiotic treatment regimens are effective in treating bacterial meningitis caused by Haemophilus influenzae?</h4><p>No research recommendation was made for this review.</p></div></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence review underpinning recommendations 1.6.4, 1.6.11 and 1.6.16 in the NICE guideline</p><p>This evidence review was developed by NICE</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2024.</div><div class="small"><span class="label">Bookshelf ID: NBK604078</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/38829972" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">38829972</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng240er16tab1"><div id="niceng240er16.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol (PICO table)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604078/table/niceng240er16.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng240er16.tab1_lrgtbl__"><table class="no_bottom_margin"><tbody><tr><th id="hd_b_niceng240er16.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng240er16.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">All adults, young people, children and babies (excluding neonates defined as aged 28 days old and younger) with confirmed bacterial meningitis caused by Haemophilus influenzae.</td></tr><tr><th id="hd_b_niceng240er16.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng240er16.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Antibiotic agent of interest:
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<ul><li class="half_rhythm"><div>Cefotaxime</div></li><li class="half_rhythm"><div>Ceftriaxone</div></li><li class="half_rhythm"><div>Amoxicillin</div></li><li class="half_rhythm"><div>Ampicillin</div></li><li class="half_rhythm"><div>Meropenem</div></li><li class="half_rhythm"><div>Chloramphenicol</div></li><li class="half_rhythm"><div>Aztreonam</div></li></ul></td></tr><tr><th id="hd_b_niceng240er16.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_niceng240er16.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><b>Stage 1 (all antibiotic agents of interest):</b>
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<ul><li class="half_rhythm"><div>Antibiotic agent A (single or combination) vs Antibiotic agent B (single or combination)</div></li></ul>
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<b>Stage 2 (antibiotic agents identified during stage 1 as most effective/for use where there are contraindications)</b>
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<ul><li class="half_rhythm"><div>Antibiotic agent A – Dose A vs Antibiotic agent A – Dose B</div></li><li class="half_rhythm"><div>Antibiotic agent A – Duration of administration A vs Antibiotic agent A – Duration of administration B</div></li><li class="half_rhythm"><div>Antibiotic agent A – Short infusion vs Antibiotic agent A – Extended infusion</div></li></ul></td></tr><tr><th id="hd_b_niceng240er16.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</th><td headers="hd_b_niceng240er16.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<b>Critical</b>
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</p>
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<p>Population: adults, children and infants
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<ul><li class="half_rhythm"><div>All-cause mortality (measured up to 1 year after discharge)</div></li><li class="half_rhythm"><div>Any long-term neurological impairment (defined as any motor deficits, sensory deficits [excluding hearing impairment], cognitive deficits*, or behavioural deficits*; measured from discharge up to 1 year after discharge)</div></li></ul>
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Population: adults
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<ul><li class="half_rhythm"><div>Functional impairment (measured by any validated scale at any time point)</div></li></ul>
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Population: children and infants
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<ul><li class="half_rhythm"><div>Severe developmental delay (defined as score of >2 SD below normal on validated assessment scales, or MDI or PDI <70 on Bayleys assessment scale, or inability to assign a score due to cerebral palsy or severity of cognitive delay; measured at the oldest age reported unless there is substantially more data available at a younger age)</div></li></ul>
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<b>Important</b></p>
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<p>Population: adults, children and infants
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<ul><li class="half_rhythm"><div>Hearing impairment (defined as any level of hearing impairment; measured from discharge up to 1 year after discharge)</div></li><li class="half_rhythm"><div>Serious intervention-related adverse effects leading to death, disability or prolonged hospitalisation or that are life threatening or otherwise considered medically significant</div></li><li class="half_rhythm"><div>CSF sterilisation (defined as treatment failure, time-to-sterilisation or delay)</div></li></ul>
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Population: adults
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<ul><li class="half_rhythm"><div>Intracranial collections as a complication (defined as abscess or empyema)</div></li></ul>
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Population: children and infants
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<ul><li class="half_rhythm"><div>Functional impairment (measured by any validated scale at any time point)</div></li></ul>
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*For infants and children below school-age, cognitive and behavioural deficits will be assessed at school-age.</p>
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</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">CSF: cerebrospinal fluid; MDI: mental development index; PDI: psychomotor development index; SD: standard deviation</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng240er16tab2"><div id="niceng240er16.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of included studies</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604078/table/niceng240er16.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng240er16.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng240er16.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng240er16.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_niceng240er16.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention</th><th id="hd_h_niceng240er16.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comparison</th><th id="hd_h_niceng240er16.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng240er16.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng240er16.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng240er16.s1.ref1" rid="niceng240er16.s1.ref1">Lapointe 1988</a>
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</p>
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<p>Retrospective cohort study</p>
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<p>Canada</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>N=62</p>
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<p>Babies and children with bacterial meningitis caused by β-lactamase-producing and ampicillin-resistant Haemophilus influenzae</p>
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<p>Age in months (mean): 16</p>
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<p>Case-fatality: 0%</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<u>Cefotaxime</u>
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</p>
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<p>IV cefotaxime 200 mg/kg/day for 10 days*</p>
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<p>*IV ampicillin 200 mg/kg/day also given in the first 48 h</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<u>Chloramphenicol</u>
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</p>
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<p>IV chloramphenicol 100 mg/kg/day for 10 days*</p>
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<p>*IV ampicillin 200-400 mg/kg/day also given in the first 48 h</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>All-cause mortality</div></li><li class="half_rhythm"><div>Any long-term neurological impairment</div></li></ul></td><td headers="hd_h_niceng240er16.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Analyses unadjusted for confounding factors</td></tr><tr><td headers="hd_h_niceng240er16.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng240er16.s1.ref2" rid="niceng240er16.s1.ref2">Molyneux 2011</a>
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</p>
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<p>RCT</p>
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<p>Bangladesh, Egypt, Malawi, Pakistan and Vietnam</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>H. influenzae N=266 (whole study N=1004)</p>
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<p>Babies and children aged 2 months to 12 years with bacterial meningitis caused by H. influenzae*, S. pneumoniae, or N. meningitides</p>
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<p>Age in months (mean; SD): 38 (42)</p>
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<p>Population treated with dexamethasone therapy: 44%</p>
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<p>Case-fatality: 4%</p>
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<p>*H. influenzae is causative organism of interest for this review</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<u>5-day ceftriaxone therapy</u>
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</p>
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<p>IV ceftriaxone 80-100 mg/kg once daily for 5 days</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<u>10-day ceftriaxone therapy</u>
|
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</p>
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<p>IV ceftriaxone 80-100 mg/kg once daily for 10 days</p>
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</td><td headers="hd_h_niceng240er16.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>All-cause mortality</div></li><li class="half_rhythm"><div>Any long-term neurological impairment</div></li><li class="half_rhythm"><div>Developmental delay</div></li><li class="half_rhythm"><div>Hearing impairment</div></li><li class="half_rhythm"><div>Serious intervention-related adverse effects</div></li><li class="half_rhythm"><div>CSF sterilisation</div></li></ul></td><td headers="hd_h_niceng240er16.tab2_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population is indirect for all outcomes except for all-cause mortality and CSF sterilisation due to 74% of population with meningitis caused by organisms other than H. influenzae</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">CSF: cerebrospinal fluid; IV: intravenous; RCT: randomised controlled trial; SD: standard deviation</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng240er16appjtab1"><div id="niceng240er16.appj.tab1" class="table"><h3><span class="label">Table 7</span><span class="title">Excluded studies and reasons for their exclusion</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK604078/table/niceng240er16.appj.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng240er16.appj.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Code [Reason]</th></tr></thead><tbody><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Baker, C. J. and Long, S. S. (2019) 50 Years Ago in the Journal of Pediatrics: Ampicillin in the Treatment of Meningitis due to Haemophilus influenzae: An Appraisal after 6 Years of Experience. Journal of Pediatrics
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208: 37
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31027633" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31027633</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design does not meet inclusion criteria</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Boisivon, A., Berardi-Grassias, L., Guiomar, C.
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et al. (1987) Bacteriostatic and bactericidal effect of ceftriaxone on Hemophilus, Neisseria meningitidis, and Proteus. Chemioterapia : international journal of the Mediterranean Society of Chemotherapy
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6(2suppl): 83–84
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[<a href="https://pubmed.ncbi.nlm.nih.gov/3151360" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 3151360</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- No comparison of interest</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Congeni, B. L. (1984) Comparison of ceftriaxone and traditional therapy of bacterial meningitis. Antimicrobial agents and chemotherapy
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25(1): 40–44
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[<a href="/pmc/articles/PMC185431/" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC185431</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/6322681" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 6322681</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population does not meet inclusion criteria</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Goldwater, Paul N. (2005) Cefotaxime and ceftriaxone cerebrospinal fluid levels during treatment of bacterial meningitis in children. International journal of antimicrobial agents
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26(5): 408–11
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[<a href="https://pubmed.ncbi.nlm.nih.gov/16216469" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 16216469</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- No outcomes of interest</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Lebel, M. H.; Hoy, M. J.; McCracken
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Jr, G. H. (1989) Comparative efficacy of ceftriaxone and cefuroxime for treatment of bacterial meningitis. Journal of Pediatrics
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114(6): 1049–1054
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2656960" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2656960</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- No comparison of interest</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Peltola, H.; Anttila, M.; Renkonen, O. V. (1989) Randomised comparison of chloramphenicol, ampicillin, cefotaxime, and ceftriaxone for childhood bacterial meningitis. Finnish Study Group. Lancet (london, england) 1(8650): 1281–1287
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2566824" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2566824</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population does not meet inclusion criteria</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Roine, I., Ledermann, W., Foncea, L. M.
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et al. (2000) Randomized trial of four vs. seven days of ceftriaxone treatment for bacterial meningitis in children with rapid initial recovery. Pediatric infectious disease journal
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19(3): 219–222
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[<a href="https://pubmed.ncbi.nlm.nih.gov/10749463" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 10749463</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population does not meet inclusion criteria</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Singhi, P., Kaushal, M., Singhi, S.
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et al. (2002) Seven days vs. 10 days ceftriaxone therapy in bacterial meningitis. Journal of tropical pediatrics
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48(5): 273–279
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[<a href="https://pubmed.ncbi.nlm.nih.gov/12405169" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12405169</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Population does not meet inclusion criteria</td></tr><tr><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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Toltzis, P. (2019) 50 Years Ago in the Journal of Pediatrics: Relapse of Hemophilus influenzae Type b Meningitis during Intravenous Therapy with Ampicillin. Journal of Pediatrics
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208: 182
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[<a href="https://pubmed.ncbi.nlm.nih.gov/31027620" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31027620</span></a>]
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</td><td headers="hd_h_niceng240er16.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">- Study design does not meet inclusion criteria</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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<script type="text/javascript" src="/portal/portal3rc.fcgi/rlib/js/InstrumentNCBIBaseJS/InstrumentPageStarterJS.js"> </script>
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<script type="text/javascript" src="//static.pubmed.gov/portal/portal3rc.fcgi/4216699/js/3968615.js" snapshot="books"></script></body>
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</html>
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