NCT00203814

A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

Open-Label, Randomised, Parallel Group in Vivo Drug Study to Evaluate Combination Anti-Malarial Therapy (CAT), Artesunate and Sulfadoxine-Pyrimethamine Versus Sulfadoxine-Pyrimethamine Alone, in Terms of Therapeutic Efficacy, Prevalence of Gametocyte Carriage and Prevalence of Molecular Markers Associated With SP Resistance In Uncomplicated Plasmodium Falciparum Infections.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (planned)
• Sponsor: University of Cape Town · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of sulfadoxine-pyrimethamine plus artesunate versus sulfadoxine-pyrimethamine alone in the treatment of uncomplicated malaria.

Detailed description

Resistance of Plasmodium falciparum to anti-malarial drugs is a serious impediment to the control of malaria. In order to facilitate formulation of effective regional drug policies and to provide a database for decision-making on the implementation of combination therapy (CAT), it is essential that the in vivo response to CAT be investigated. In the South East African Combination Anti-malarial Therapy (SEACAT) evaluation, there is a comprehensive evaluation of the phased introduction of combination anti-malarial therapy in Mozambique. As a component of this evaluation, in selected Mozambique sites where intensity of malaria transmission is high, a direct parallel group comparison of monotherapy (SP) with CAT (artesunate plus SP) will be conducted according to this protocol.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Sulfadoxine-pyrimethamine
DRUG	Artesunate plus sulfadoxine-pyrimethamine

Timeline

• Start date: 2004-01-01
• Completion: 2005-03-01
• First posted: 2005-09-20
• Last updated: 2006-11-16

Locations

2 sites across 1 country: Mozambique