EDCTP contributes to the fight against malaria by funding research into development of more new drugs and drug combinations, clinical development of novel vaccine candidates and enhanced clinical trials capacity in Africa. EDCTP projects include studies of both artemisinin based combination therapies (ACTs) and non ACTs, aiming at establishing therapies that are safe and highly effective in real world situations. Ongoing studies involve special patient groups such as infants, malnourished children, HIV/AIDS co-infected individuals and pregnant mothers. Additionally, EDCTP supports clinical research and development of candidate malaria vaccines that include MVA METRAP, AdCh63 ME-TRAP and GMZ2.

Among EDCTP-funded malaria projects are the following clinical trials:

As part of studies involving pregnancy associated malaria, EDCTP funds a project that aims to optimise the existing dose and regimen of intermittent preventive treatment with sulfadoxine-pyrimethamine. This treatment is to prevent malaria in pregnant women in areas where there is a high coverage of insecticide treated nets and where malaria transmission is highly seasonal. The study compares intermittent preventive treatment (IPTp) with intermittent screening and treatment of malaria (IST).

In Zambia, Malawi and Mozambique EDCTP funds a phase III/IV clinical trial to identify safe and efficacious ACTs that can be administered to HIV-positive patients who receive antiretroviral medication and in very young or malnourished children. Concurrently, the study aims to establish the appropriate age-based dosing where weight-based dosing is not feasible. This study started recruiting patients in August 2010.

EDCTP is also funding a phase IIIb/IV clinical study is to assess the safety and efficacy of repeated administration of four repeated ACTs over a two-year period in children and adult patients with acute uncomplicated malaria. This project is being carried out by the West African Network for Clinical Trials of Anti Malarial drugs (WANECAM). The study is expected to generate important safety and efficacy data that will contribute to the registration of the new generation ACT’s: pyronaridine-artesunate and dihydroartemisinin-piperaquine.

EDCTP-funded research into the efficacy of a novel antimalaria agent, fosmidomycin, has started in 2010. This phase II/III clinical trial aims to determine the optimal therapeutic regime for administering fosmidomycin together with clindamycin to children suffering from acute uncomplicated malaria. This project is taking place in Mozambique, Benin, Gabon and Tanzania.

All these projects reflect EDCTP strategy of integrating regulatory quality research with investment in clinical capacity development and expanding research networks in sub-Saharan Africa.

About EDCTP

The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union member states plus Norway and Switzerland with 47 sub-Saharan African countries. The aim of the programme is to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through promoting the integration of national programmes of EDCTP European Member States and development of a genuine partnership with African counterparts.

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Note to the editor:

For further information, please contact:
Gert Onne van de Klashorst, press officer
Phone: +31 (0)70 344 0885
Email: media[at]edctp.org.

External links:

• Roll back Malaria Partnership – key facts on malaria
• World Malaria Report 2010
• Global Malaria Action Plan