Status:
COMPLETED
Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Medical Research Council
National Malaria Control Programme, The Gambia
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the firs...
Detailed Description
Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falcip...
Eligibility Criteria
Inclusion
- Presentation at health centre with febrile illness
- Monoinfection with P. falciparum
- Parasitaemia \>=500/microlitre
- Fever or history of fever
Exclusion
- Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia \>200,000/ul)
- Severe malnutrition
- Clinically evident concomitant disease
- PCV \<20%
- History of allergy to the study medications
- Residence outside the study area and hence difficult to follow up
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT00118807
Start Date
August 1 2003
End Date
February 1 2004
Last Update
January 9 2006
Active Locations (1)
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1
Medical Research Council Laboratories
Banjul, City of Banjul, The Gambia, POBOX273