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Cotrimoxazole Prophylaxis in Severely Malnourished Children

NCT00934492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1781

Last updated 2014-08-18

No results posted yet for this study

Summary

This trial aims to test the hypothesis that mortality among Kenyan children with severe malnutrition following initial stabilisation is due to ongoing vulnerability to infectious disease, and that long term daily co-trimoxazole prophylaxis will reduce mortality.

The objective is to conduct a randomized, double blind, placebo-controlled trial of cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe malnutrition following stabilization. The primary outcome will be survival at one year. Secondary outcomes are toxicity, growth, the frequency and causes of hospitalisation and microbial resistance to antibiotics.

Cotrimoxazole has striking protective efficacy against mortality among children with HIV, despite not altering the underlying immune deficiency. It is hypothesised that co-trimoxazole prophylaxis will have a similar effect in children immunocompromised because of severe malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and co-trimoxazole is cheap and widely available, making it easily translatable to policy.

Conditions

  • Nutrition Disorders
  • Life-threatening Infection

Interventions

DRUG

Cotrimoxazole dispersible tablet

Cotrimoxazole dispersible tablets 120/240mg daily for six consecutive months.

DRUG

Placebo dispersible tablet

Placebo dispersible tablets 120/240mg daily for six consecutive months.

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • James A Berkley, FRCPCH · Universitiy of Oxford & Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Kenya

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 NCT00934492 on ClinicalTrials.gov