Twenty-four Month Outcomes of Extended- Versus Standard-course Antibiotic Therapy in Children Hospitalized With Pneumonia in High-risk Settings: A Randomized Controlled Trial
Document Type
Article
Publication Date
9-1-2024
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.
Keywords
hospitalized pneumonia, long-term effects, antibiotic duration, controlled trials, child
Divisions
paediatrics
Funders
National Health & Medical Research Council (NHMRC) of Australia (1098443) ; (1040830),Cure-Kids, New Zealand (3571),University of Malaya Research Grant (RP026-14HTM),Charles Darwin International PhD Scholars (CDIPS) Scholarship,National Health & Medical Research Council (NHMRC) of Australia (2025379),Senior Practitioner Fellowship (1154302)
Publication Title
Pediatric Infectious Disease Journal
Volume
43
Issue
9
Publisher
Lippincott, Williams & Wilkins
Publisher Location
TWO COMMERCE SQ, 2001 MARKET ST, PHILADELPHIA, PA 19103 USA