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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Treatments: Amoxicillin; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Children aged 2-59 months with non severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off

• Accessible to follow up

• Written informed consent from the parent/caretaker

Exclusion Criteria:

• Children with severe pneumonia

• Documented use of antibiotics for the last 48 hours

• Confirmed HIV positive on cotrimoxazole prophylaxis

• Three or more episodes of wheezing in a year with asthmatic attack

• History of hospitalization within last 15 days

• Measles within last one month

• Previous history of allergy to cotrimoxazole or amoxicillin