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Extended Versus Standard Antibiotic Course Duration in Children <5 Years of Age Hospitalized With Community-acquired
Gabrielle B McCallum1, Siew M Fong2, Keith Grimwood3,4
1From the Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Insights
For children hospitalized with pneumonia, an extended antibiotic course showed no benefit over a standard course for clinical cure at four weeks. Further research is needed to determine any longer-term advantages of extended antibiotic treatment.
Area of Science:
- Pediatric infectious diseases
- Clinical pharmacology
- Respiratory medicine
Background:
- Limited evidence exists on optimal antibiotic duration for community-acquired pneumonia (CAP) in hospitalized children, particularly those at risk for chronic respiratory disorders.
- This study addresses the need for high-level evidence regarding antibiotic treatment strategies in vulnerable pediatric populations.
Purpose of the Study:
- To determine if an extended antibiotic course is superior to a standard course for achieving clinical cure at 4 weeks in children hospitalized with CAP.
- To evaluate secondary outcomes including adverse events and nasopharyngeal bacterial carriage and resistance.
Main Methods:
- A multinational, double-blind, randomized controlled trial involving children aged 3 months to 5 years with radiographic-confirmed CAP.
- Participants received initial intravenous antibiotics followed by oral amoxicillin-clavulanate, then were randomized to either an extended (13-14 days) or standard (5-6 days) antibiotic duration.
- Clinical cure at 4 weeks post-enrollment was the primary outcome, assessed via intention-to-treat analysis.
Main Results:
- Clinical cure rates were similar between the extended (77.9%) and standard (81.3%) antibiotic groups at 4 weeks.
- No significant differences were observed in adverse events or nasopharyngeal carriage of key bacterial pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus) or antimicrobial resistance between the groups.
- The study included 324 children who met the inclusion criteria and were randomized.
Conclusions:
- An extended antibiotic course was not superior to a standard course for achieving clinical cure at 4 weeks in children hospitalized with pneumonia and at risk for chronic respiratory illnesses.
- Further investigation is warranted to explore potential longer-term benefits of extended antibiotic regimens in this population.
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.
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