drugset / Trial / NCT00243737

Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria

NCT00243737

Phase 2 Completed 70 enrolled Albert Schweitzer Hospital Mepha Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Treatment of Plasmodium falciparum malaria in Africa is increasingly difficult. Resistance to cheap efficient antimalarial drugs poses an increasing threat. The rapid emergence of resistance to sulfadoxine - pyrimethamine, already seen in East Africa is growing and is likely to have an striking impact on mortality in many other African regions where no obvious alternatives are available. WHO recommends the use of drug combinations containing artemisinin compounds, i.e., artemisinin-based combination therapies (ACT). Previous clinical trials have shown that the combination of artesunate with mefloquine is highly effective and well tolerated in the treatment of multidrug-resistant falciparum malaria, retaining the benefit of rapidity of action while augmenting cure rates, and apparently slowing the development of mefloquine resistance. Compliance with sequential combination regimen of antimalarial drugs is notoriously poor. Therefore, in order to limit the development of resistance to both drugs and ameliorate patients' compliance to antimalarial treatments, an optimal simultaneous combination regimen of artesunate and mefloquine in a practical single blister pack has been developed by Mepha Ltd. and successfully tested. The currently available

Timeline

Start
2005-10
Primary completion
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Artesunate Small molecule 50 mg Oral
Subject Mefloquine Unknown 125 mg Oral

Indications