Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission

Phase 3

Completed

• Conditions: Plasmodium Falciparum; Asymptomatic Parataemia; Sub Patent Parasitaemia
• Interventions: Drug: Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS); Drug: placebo tablet similar to active drug in shape and size

• Registration Number: NCT00646126
• Lead Sponsor: Tropical Medicine Research Institute

Brief Summary

The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-08
• Study Start: 2005-08
• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Last Update Submitted: 2008-03-27
• Study First Posted: 2008-03-28
• Last Update Posted: 2008-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All residents of the 8 villages

Exclusion Criteria

• Pregnancy
• History of allergy to sulfa drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)	1:Active comparator sulfadoxine-pyrimethamine plus artesunate
2	placebo tablet similar to active drug in shape and size	2:placebo comparator

Primary Outcome Measures

Name	Time	Method
Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages	October to December 2006

Secondary Outcome Measures

Name	Time	Method
1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes

Trial Locations

Locations (1)

Tropical Medicine Research Institute; 🇸🇩 Khartoum, Sudan