drugset / Trial / NCT00519467

Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria

NCT00519467

Phase 2 Completed 120 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT. Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.

Timeline

Start
2003-06
Primary completion
2005-02
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Artesunate Small molecule 1 mg/kg
Subject Artesunate Small molecule 2 mg/kg
Subject Artesunate Small molecule 4 mg/kg
Background Dapsone Small molecule 2.5 mg/kg
Background chlorproguanil Small molecule 2 mg/kg