Efficacy, Safety and Pharmacokinetic of ArtequinTM P. Falciparum Malaria
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
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