A Phase 3 interventional study of Amodiaquine plus artesunate (AQ/AS) and Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ) in Malaria, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Gambia. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2006-01-09.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Treatment
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.
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 falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 1,800 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical failure by day 28
Incidence of adverse events
Compliance with treatment regimen
Parasitological failure by day 28
Clinical failure by day 14
Parasitological failure rate by day 14
Mean PCV on day 28
Gametocyte carriage rates
Transmissibility after treatment
This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.
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London School of Hygiene and Tropical Medicine