Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medecins Sans Frontieres, Netherlands
• Collaborators: Disease Control, Department of Health, Myanmar; Mahidol University; University of Oxford
• Treatments: Amodiaquine; Artemether-lumefantrine combination; Artemisinine; Artemisinins; Artesunate; Dihydroartemisinin; Mefloquine; Piperaquine

Criteria

Inclusion criteria

• Age over 6 months and

• Weight ≥ 5 kg, and

• Slide-confirmed infection with Plasmodium falciparum (including mixed infections), and

• Asexual parasite density between 500 and 200,000/µl of blood, and

• Informed consent from a parent or guardian aged at least 18 years.

Exclusion criteria

• General danger signs according to the WHO definition or

• Signs of severe/complicated malaria according to the WHO definition or

• Severe anaemia (haemoglobin < 5 g/dL), or

• Known history of hypersensitivity to any of the study drugs, or

• Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet), or

• Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc.; mild flu should not lead to exclusion) or

• History of psychiatric diseases, or

• Having received a full course treatment including MQ in the preceding 9 weeks or

• Having received any other antimalarials in the previous 48 hours.