Cotrimoxazole Versus Amoxicillin in the Treatment of Community Acquired Pneumonia in Children Aged 2-59 Months
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.
1 other identifier
interventional
505
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2007
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 5, 2009
CompletedFirst Posted
Study publicly available on registry
July 7, 2009
CompletedJuly 7, 2009
July 1, 2009
6 months
July 5, 2009
July 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Normalisation of respiratory rate to age specific range by day 3 of treatment
3 days
Secondary Outcomes (1)
Antimicrobial susceptibility to cotrimoxazole and amoxicillin
10 days
Study Arms (2)
Cotrimoxazole
ACTIVE COMPARATORCotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole) + Amoxicillin placebo
Amoxicillin
ACTIVE COMPARATORAmoxicillin (25 mg/kg/dose) + Cotrimoxazole placebo
Interventions
Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Makerere University
Kampala, Uganda
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joyce M Kaducu, MBChB, MMED
Makerere University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2009
First Posted
July 7, 2009
Study Start
July 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
July 7, 2009
Record last verified: 2009-07