drugset / Trial / NCT07647835

3 vs. 5 Days of Amoxicillin for Childhood Pneumonia: An RCT

NCT07647835

Phase 0 Not yet recruiting 250 enrolled Khyber Teaching Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

Pneumonia is the most common infection in children and leading to most common cause of mortality and morbidity in in children globally. Bacterial cause is mostly streptococcus pneumonia in children of 3 months to 5 years of age. Traditionally 7-10 antibiotic is used for uncomplicated community acquired pneumonia. World health organization (WHO) recommends 5 days of antibiotic for non-severe pneumonia with oral amoxicillin while National institute for health and care excellence (NICE) guidelines 2025 recommends 3-days course of amoxicillin in uncomplicated community acquired pneumonia.1,2 Most studies show Short course antibiotic is as effective as long course of antibiotic with fewer side effect. The Khyber Pakhtunkhwa province faces particular challenges due to limited healthcare access, malnutrition, and suboptimal vaccination coverage which leads to major burden of pneumonia in less than 5 years' children.7 There is need of local data about effectiveness of short course antibiotic in uncomplicated community acquired pneumonia. 3-day oral amoxicillin has better compliance and less side effect of medicine. Short course of oral amoxicillin is cost effective as pneumonia is more common in low socioeconomic population and 3-day course antibiotic is more economical and has better compliance. Long course of antibiotic leads to antibiotic resistance and adverse effects like diarrhea and other gastrointestinal symptoms.

Timeline

Start
2026-06-01
Primary completion
2027-06-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 80 mg/kg Oral
Subject Amoxicillin Other / unclassified 90 mg/kg Oral

Indications