Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized...

Area of Science:

• Pediatric infectious diseases
• Clinical pharmacology
• Antimicrobial stewardship

Background:

• Community-acquired pneumonia (CAP) is a common childhood illness.
• Current guidelines recommend 10 days of high-dose amoxicillin for non-severe CAP.
• Shorter antibiotic courses may reduce harms like antibiotic resistance and microbiome disruption.

Purpose of the Study:

• To determine if a 5-day course of high-dose amoxicillin is non-inferior to a 10-day course for treating non-severe pediatric CAP.
• To provide evidence for optimizing antimicrobial treatment durations in children.

Main Methods:

• Multicenter, randomized, non-inferiority, controlled trial.
• Comparing 5 days of high-dose amoxicillin versus 10 days in children with non-severe CAP.
• Includes multiplex respiratory virus testing, genomic load quantification, and microbiome profiling.

Main Results:

• This section is not yet available as the study is ongoing or results are pending.
• The study aims to recruit 270 participants, with 60 from a previous feasibility study.

Conclusions:

• This pragmatic trial will inform front-line physicians treating pediatric CAP in North America.
• Evidence on the non-inferiority of short-course therapy for non-severe pediatric CAP is needed before guideline changes.
• The study is registered on ClinicalTrials.gov (NCT02380352).