Status:
COMPLETED
Cotrimoxazole Prophylaxis in Severely Malnourished Children
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Kenya Medical Research Institute
Conditions:
Nutrition Disorders
Life-threatening Infection
Eligibility:
All Genders
2-5 years
Phase:
PHASE3
Brief 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 lon...
Detailed Description
Malnutrition is the most important underlying risk factor for childhood death in developing countries. Severely malnourished children are at greatly increased risk of death from infectious diseases in...
Eligibility Criteria
Inclusion
- Age 2 months to 5 years
- Admitted to hospital
- Severe malnutrition: age 6 months to 5 years: MUAC \<11cm; age 2 to 6 months: MUAC for age \<-3 z scores compared to the WHO growth standards; or kwashiorkor at any age (defined in current WHO guidelines) for enrollments up to 24th March 2011.
- Severe malnutrition:age 6 months to 5 years: MUAC \<11.5cm; age 2 to 6 months: MUAC \<11.0cm; or kwashiorkor at any age (defined in current WHO guidelines) for enrollments from 24th March 2011, following protocol amendment.
- HIV rapid test negative, or if under 18 months, PCR negative and no longer breastfeeding for at least 6 weeks
- Planning to remain within study area and willing to come for all protocol specified visits
Exclusion
- Refusal to give informed consent
- Cotrimoxazole is specifically contra-indicated (e.g. porphyria)
- Known hypersensitivity reaction to sulpha drugs or trimethoprim
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1781 Patients enrolled
Trial Details
Trial ID
NCT00934492
Start Date
November 1 2009
End Date
April 1 2014
Last Update
August 18 2014
Active Locations (4)
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1
KEMRI/Wellcome Trust Research Programme
Kilifi, Coast, Kenya, 80108
2
Malindi District Hospital
Malindi, Coast, Kenya
3
Coast Provincial General Hospital
Mombasa, Coast, Kenya
4
Mbagathi District Hospital
Nairobi, Kenya