Twenty-four Month Outcomes of Extended- Versus Standard-course Antibiotic Therapy in Children Hospitalized With Pneumonia in High-risk Settings: A Randomized Controlled Trial

Kok HC 1 , McCallum GB 1 , Yerkovich ST 1 , Grimwood K 2 , Fong SM 3 , Nathan AM 4 Show all authors , Byrnes CA 5 , Ware RS 2 , Nachiappan N 6 , Saari N 6 , Morris PS 1 , Yeo TW 1 , Oguoma VM 1 , Masters IB 7 , de Bruyne JA 4 , Eg KP 4 , Lee B 1 , Ooi MH 8 , Upham JW 9 , Torzillo PJ 10 , Chang AB 1

Affiliations 

  • 1 From the Child and Maternal Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia
  • 2 School of Medicine and Dentistry, Griffith University, Gold Coast, Queensland, Australia
  • 3 Department of Pediatrics, Sabah Women and Children's Hospital, Kota Kinabalu, Sabah, Malaysia
  • 4 Department of Pediatrics, University of Malaya, Kuala Lumpur, Malaysia
  • 5 Department of Pediatrics, University of Auckland, Auckland, New Zealand
  • 6 Department of Pediatrics, Tengku Ampuan Rahimah Hospital, Klang, Selangor, Malaysia
  • 7 Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, Australia
  • 8 Department of Pediatrics, Sarawak General Hospital, Sarawak, Malaysia
  • 9 Diamantina Institute, The University of Queensland, and Translational Research Institute, Brisbane, Queensland, Australia
  • 10 Central Clinical School, University of Sydney, Sydney, New South Wales, Australia
Pediatr Infect Dis J, 2024 Sep 01;43(9):872-879.
PMID: 38830139 DOI: 10.1097/INF.0000000000004407

Abstract

BACKGROUND: Pediatric community-acquired pneumonia (CAP) can lead to long-term respiratory sequelae, including bronchiectasis. We determined if an extended (13-14 days) versus standard (5-6 days) antibiotic course improves long-term outcomes in children hospitalized with CAP from populations at high risk of chronic respiratory disease.

METHODS: We undertook a multicenter, double-blind, superiority, randomized controlled trial involving 7 Australian, New Zealand, and Malaysian hospitals. Children aged 3 months to ≤5 years hospitalized with radiographic-confirmed CAP who received 1-3 days of intravenous antibiotics, then 3 days of oral amoxicillin-clavulanate, were randomized to either extended-course (8-day oral amoxicillin-clavulanate) or standard-course (8-day oral placebo) arms. Children were reviewed at 12 and 24 months. The primary outcome was children with the composite endpoint of chronic respiratory symptoms/signs (chronic cough at 12 and 24 months; ≥1 subsequent hospitalized acute lower respiratory infection by 24 months; or persistent and/or new chest radiographic signs at 12-months) at 24-months postdischarge, analyzed by intention-to-treat, where children with incomplete follow-up were assumed to have chronic respiratory symptoms/signs ("worst-case" scenario).

RESULTS: A total of 324 children were randomized [extended-course (n = 163), standard-course (n = 161)]. For our primary outcome, chronic respiratory symptoms/signs occurred in 97/163 (60%) and 94/161 (58%) children in the extended-courses and standard-courses, respectively [relative risk (RR) = 1.02, 95% confidence interval (CI): 0.85-1.22]. Among children where all sub-composite outcomes were known, chronic respiratory symptoms/signs between groups, RR = 1.10, 95% CI: 0.69-1.76 [extended-course = 27/93 (29%) and standard-course = 24/91 (26%)]. Additional sensitivity analyses also revealed no between-group differences.

CONCLUSION: Among children from high-risk populations hospitalized with CAP, 13-14 days of antibiotics (versus 5-6 days), did not improve long-term respiratory outcomes.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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