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

Phase 3

Completed

• Conditions: Plasmodium Infections
• Interventions: Drug: sulfadoxine-pyrimethamine (SP) plus artesunate (AS); Drug: primaquine (PQ) plus SP+AS

• Registration Number: NCT00330902
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-11
• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-29
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• infection with P.falciparum detected by PCR

Exclusion Criteria

• pregnancy
• severe anaemia
• fever or other signs of illness
• history of allergy to sulfa drugs
• presence of other species of Plasmodium detected by microscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sulfadoxine-pyrimethamine (SP) plus artesunate (AS)	Sulfadoxine pyrimethamine plus three daily doses of artesunate
2	primaquine (PQ) plus SP+AS	Sulfadoxine pyrimethamine plus artesunate plus primaquine

Primary Outcome Measures

Name	Time	Method
P.falciparum parasitaemia detected by PCR on days 3,7 and 14.	14 days from start of treatment

Secondary Outcome Measures

Name	Time	Method
Presence of gametocytes detected by RT-PCR on days 3, 7 and 14.	14 days from start of treatment
Packed Cell volume on days 7 and 14.	Over 14 days from start of treatment

Trial Locations

Locations (1)

Tropical Medicine Research Institute; 🇸🇩 Khartoum, Sudan