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Sponsored by: |
Makerere University |
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Information provided by: | Makerere University |
ClinicalTrials.gov Identifier: | NCT00933049 |
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.
Condition | Intervention | Phase |
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Childhood Pneumonia |
Drug: Amoxicillin Drug: Cotrimoxazole Drug: Amoxicillin placebo Drug: Cotrimoxazole placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Clinical Efficacy of Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months Attending Mulago Hospital: A Randomized Clinical Trial. |
Enrollment: | 505 |
Study Start Date: | July 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cotrimoxazole: Active Comparator
Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole) + Amoxicillin placebo
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Drug: Cotrimoxazole
Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole)
Drug: Amoxicillin placebo
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Amoxicillin: Active Comparator
Amoxicillin (25 mg/kg/dose) + Cotrimoxazole placebo
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Drug: Amoxicillin
Oral amoxicillin (25mg/kg/dose)for 5 days
Drug: Cotrimoxazole placebo
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Ages Eligible for Study: | 2 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Faculty of Medicine, Makerere University ( Prof James K Tumwine ) |
Study ID Numbers: | 2005HD11/3472U |
Study First Received: | July 5, 2009 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00933049 History of Changes |
Health Authority: | Uganda: National Council for Science and Technology |
Efficacy children pneumonia cotrimoxazole amoxicillin |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Trimethoprim Amoxicillin Sulfamethoxazole |
Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Anti-Infective Agents, Urinary Trimethoprim-Sulfamethoxazole Combination Pneumonia |
Anti-Infective Agents Antiprotozoal Agents Amoxicillin Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions Anti-Bacterial Agents |
Antimalarials Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Therapeutic Uses Pneumonia |