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

• Published in: Pediatric Infectious Disease Journal
• Main Authors: McCallum, Gabrielle B., Fong, Siew M., Grimwood, Keith, Nathan, Anna M., Byrnes, Catherine A., Ooi, Mong H., Nachiappan, Nachal, Saari, Noorazlina, Morris, Peter S., Yeo, Tsin W., Ware, Robert S., Elogius, Blueren W., Oguoma, Victor M., Yerkovich, Stephanie T., de Bruyne, Jessie, Lawrence, Katrina A., Lee, Bilawara, Upham, John W., Torzillo, Paul J., Chang, Anne B.
• Format: Article in Journal/Newspaper
• Language: English
• Published: Ovid Technologies (Wolters Kluwer Health) 2022
• Subjects: First Nations
• Online Access: http://dx.doi.org/10.1097/inf.0000000000003558; https://journals.lww.com/10.1097/INF.0000000000003558

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.