Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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 first dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Medical Research Council; National Malaria Control Programme, The Gambia
• Treatments: Amodiaquine; Artesunate; Chloroquine; Chloroquine diphosphate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Presentation at health centre with febrile illness

• Monoinfection with P. falciparum

• Parasitaemia >=500/microlitre

• Fever or history of fever

Exclusion Criteria:

• 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