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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 October 19, 2014