NCT00330902

Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan

Randomized Trial of Sulfadoxine-Pyrimethamine Plus Artesunate (SP+AS) Versus SP+AS Plus Primaquine for Clearance of Low Density P. Falciparum Infection in Eastern Sudan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

In areas of seasonal malaria transmission, treatment of carriers of malaria parasites, whose parasitaemia persists at very low levels throughout the dry season, could be a useful strategy for malaria control in areas with a short transmission season. We did a randomized trial to compare two regimens for clearance of low level parasitaemia in the dry season.

Detailed description

104 individuals with low density Plasmodium falciparum infection detected by polymerase chain reaction (PCR) were randomized to receive sulfadoxine-pyrimethamine and three daily doses of artesunate (SP+AS) or SP+AS and a dose of primaquine (SP+AS+PQ), and were followed up for 14 days during the transmission-free season in Eastern Sudan. Subjects were visited on days 3, 7 and 14 after the start of treatment to record any adverse events and to detect P.falciparum using PCR. PCR positive samples were tested for gametocytes using RT-PCR. Packed cell volume was measured on days 7 and 14.

Conditions

• Plasmodium Infections

Interventions

Type	Name	Description
DRUG	sulfadoxine-pyrimethamine (SP) plus artesunate (AS)	sulfadoxine-pyrimethamine (SP) plus three daily doses of artesunate (AS)
DRUG	primaquine (PQ) plus SP+AS	single dose of primaquine on day 4

Timeline

• Start date: 2004-01-01
• Completion: 2004-11-01
• First posted: 2006-05-29
• Last updated: 2007-10-31

Locations

1 site across 1 country: Sudan