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

This study has been completed.
Sponsor:
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00933049
First received: July 5, 2009
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  Purpose

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
Childhood Pneumonia
 Drug: Amoxicillin
Drug: Cotrimoxazole
Drug: Amoxicillin placebo
Drug: Cotrimoxazole placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Normalisation of respiratory rate to age specific range by day 3 of treatment [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antimicrobial susceptibility to cotrimoxazole and amoxicillin [ Time Frame: 10 days ] [ Designated as safety issue: No ]

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
Active Comparator: Cotrimoxazole
Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole) + Amoxicillin placebo
 Drug: Cotrimoxazole
Cotrimoxazole (8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole)
Other Name: CTX
Drug: Amoxicillin placebo
Active Comparator: Amoxicillin
Amoxicillin (25 mg/kg/dose) + Cotrimoxazole placebo
 Drug: Amoxicillin
Oral amoxicillin (25mg/kg/dose)for 5 days
Other Name: AMOX
Drug: Cotrimoxazole placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933049

Locations
Uganda
Faculty of Medicine, Makerere University
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Investigators
Principal Investigator: Joyce M Kaducu, MBChB, MMED Makerere University
  More Information

No publications provided

Responsible Party: Prof James K Tumwine, Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier: NCT00933049     History of Changes
Other Study ID Numbers: 2005HD11/3472U
Study First Received: July 5, 2009
Last Updated: July 6, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Efficacy
children
pneumonia
cotrimoxazole
amoxicillin

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Sulfamethoxazole
Trimethoprim-Sulfamethoxazole Combination
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 22, 2013