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

NCT00933049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2009-07-07

No results posted yet for this study

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.

Conditions

  • Childhood Pneumonia

Interventions

DRUG

Amoxicillin

Oral amoxicillin (25mg/kg/dose)for 5 days

DRUG

Cotrimoxazole

Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole)

DRUG

Amoxicillin placebo

DRUG

Cotrimoxazole placebo

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Joyce M Kaducu, MBChB, MMED · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933049 on ClinicalTrials.gov