Studies begin for new antimalarial in sub-Saharan Africa
Phase III studies assessing the safety and efficacy of chlorproguanil hydrochloride-dapsone-artesunate (CDA) in treating acute, uncomplicated Plasmodium falciparum malaria are to take place in sites across sub-Saharan Africa
Phase III studies assessing the safety and efficacy of chlorproguanil hydrochloride-dapsone-artesunate (CDA) in treating acute, uncomplicated Plasmodium falciparum malaria are to take place in sites across sub-Saharan Africa
CDA is being developed as a fixed-dose combination to meet the urgent need for new malaria treatments in the developing world where multi-drug resistance is contributing to an escalating health crisis. More than 90% of the malaria cases and the great majority of deaths occur in sub-Saharan Africa, where P. falciparum malaria is the most common form.
Currently, the Global Malaria Programme of the World Health Organization (WHO) recommends that National Malaria Control Programmes use artemisinin-based combination therapies (ACT) for the treatment of uncomplicated malaria in the public sector.
Two Phase III trials for CDA will involve almost 2,300 children, adolescents and adults. One study will evaluate CDA relative to artemether/lumefantrine (Coartem), currently the most widely registered and used fixed-dose ACT for the treatment of P. falciparum malaria. This study will measure the parasitological cure rate at 28 days, as well as safety and parasite and fever clearance times.
The second study will compare CDA's efficacy at 28 days to that of Lapdap, a fixed-dose combination pill containing two well-established antimalarial agents, chlorproguanil and dapsone. The study will also determine the advantage of CDA over Lapdap in terms of parasite clearance at 24 hours following the first dose.
CDA is being developed by GlaxoSmithKline (GSK), UNICEF/UNDP/World Bank, WHO Special Programme for Research and Training in Tropical Diseases and MMV. Academic partners in its development are the University of Liverpool, Liverpool School of Tropical Medicine and the London School of Hygiene & Tropical Medicine, as well as clinical investigators across sub-Saharan Africa.
If its development is successful, CDA will be supplied at affordable, preferential prices to the public sector in malaria-endemic developing countries to maximise access for those in need.
Malaria kills one child every 30 seconds, and many children who survive an episode of cerebral malaria suffer from learning impairments or brain damage. Malaria is having a significant economic impact in endemic countries, costing Africa US$12 bn in lost GDP every year and consuming 40 % of all public health spending.