Journal article
Extended Versus Standard Antibiotic Course Duration in Children 5 Years of Age Hospitalized With Community-acquired Pneumonia in High-risk Settings: Four-week Outcomes of a Multicenter, Double-blind, Parallel, Superiority Randomized Controlled Trial
The Pediatric Infectious Disease Journal, Vol.41(7), pp.549-555
2022
PMID: 35476706
Abstract
Background:
High-level evidence is limited for antibiotic duration in children hospitalized with community-acquired pneumonia (CAP) from First Nations and other at-risk populations of chronic respiratory disorders. As part of a larger study, we determined whether an extended antibiotic course is superior to a standard course for achieving clinical cure at 4 weeks in children 3 months to ≤5 years old hospitalized with CAP.
Methods:
In our multinational (Australia, New Zealand, Malaysia), double-blind, superiority randomized controlled trial, children hospitalized with uncomplicated, radiographic-confirmed, CAP received 1–3 days of intravenous antibiotics followed by 3 days of oral amoxicillin-clavulanate (80 mg/kg, amoxicillin component, divided twice daily) and then randomized to extended (13–14 days duration) or standard (5–6 days) antibiotics. The primary outcome was clinical cure (complete resolution of respiratory symptoms/signs) 4 weeks postenrollment. Secondary outcomes included adverse events, nasopharyngeal bacterial pathogens and antimicrobial resistance at 4 weeks.
Results:
Of 372 children enrolled, 324 fulfilled the inclusion criteria and were randomized. Using intention-to-treat analysis, between-group clinical cure rates were similar (extended course: n = 127/163, 77.9%; standard course: n = 131/161, 81.3%; relative risk = 0.96, 95% confidence interval = 0.86–1.07). There were no significant between-group differences for adverse events (extended course: n = 43/163, 26.4%; standard course, n = 32/161, 19.9%) or nasopharyngeal carriage of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Staphylococcus aureus or antimicrobial resistance.
Conclusions:
Among children hospitalized with pneumonia and at-risk of chronic respiratory illnesses, an extended antibiotic course was not superior to a standard course at achieving clinical cure at 4 weeks. Additional research will identify if an extended course provides longer-term benefits.
Details
- Title
- Extended Versus Standard Antibiotic Course Duration in Children 5 Years of Age Hospitalized With Community-acquired Pneumonia in High-risk Settings: Four-week Outcomes of a Multicenter, Double-blind, Parallel, Superiority Randomized Controlled Trial
- Authors
- Gabrielle B. McCallum (Corresponding Author) - Menzies School of Health ResearchSiew M. Fong - HL-MALKeith Grimwood - Gold Coast HealthAnna M. Nathan - University of MalayaCatherine A. Byrnes - University of AucklandMong H. Ooi - Sarawak General HospitalNachal Nachiappan - Tengku Ampuan Rahimah HospitalNoorazlina Saari - Tengku Ampuan Rahimah HospitalPeter S Morris - Charles Darwin UniversityTsin W. Yeo - Charles Darwin UniversityRobert Ware - Griffith UniversityBlueren W. Elogius - Sabah Environmental TrustVictor M Oguoma - University of the Sunshine Coast, Queensland, Thompson InstituteStephanie T. Yerkovich - Charles Darwin UniversityJessie A. de Bruyne - University of MalayaKatrina A. Lawrence - Charles Darwin UniversityBilawara Lee - Charles Darwin UniversityJohn W. Upham - Translational Research InstitutePaul J. Torzillo - Menzies School of Health ResearchAnne B Chang - Charles Darwin University
- Publication details
- The Pediatric Infectious Disease Journal, Vol.41(7), pp.549-555
- Publisher
- Lippincott Williams & Wilkins
- Date published
- 2022
- DOI
- 10.1097/INF.0000000000003558
- ISSN
- 1532-0987; 0891-3668
- PMID
- 35476706
- Grants
- Grant note
- The New Zealand site was supported by a 2-year grant from CureKids, New Zealand (grant 3571). The Kuala Lumpur site was partially funded by a Malaysian Health grant RP026-14HTM.
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 991120252302621
- Output Type
- Journal article
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- Immunology
- Infectious Diseases
- Pediatrics
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