drugset / Trial / NCT00933049

Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months

NCT00933049

Phase 3 Completed 505 enrolled Makerere University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The investigators hypothesized that Oral amoxicillin (25mg/kg/dose bid) given to children aged 2-59 months with pneumonia, would lead to better clinical outcome on day three in 89.9% of the children compared to 77.0% of children receiving oral cotrimoxazole (8 mg/kg/dose trimethoprim, 40 mg/kg/dose sulphamethoxazole). A double blind randomized controlled trial was conducted in the Assessment Center of Mulago Hospital. Children with non-severe pneumonia were randomized to receive either oral amoxicillin (25 mg/kg/dose) or cotrimoxazole (trimethoprim 8 mg/kg and sulphamethoxazole 40 mg/kg) and followed up on day 3 and 5 of treatment. The primary outcome measures were normalization of respiratory rate by day 3 of treatment. Secondary outcome measures were antimicrobial susceptibility to cotrimoxazole and amoxicillin.

Timeline

Start
2007-07
Primary completion
2008-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 25 mg/kg Oral
Comparator Sulfamethoxazole Small molecule 40 mg/kg Oral
Comparator Trimethoprim Small molecule 8 mg/kg Oral

Indications