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Sponsors and Collaborators: |
Gates Malaria Partnership Kintampo Health Research Centre, Ghana |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00119145 |
Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies.
Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen.
This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial.
The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.
Condition | Intervention | Phase |
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Malaria |
Drug: artesunate-amodiaquine Drug: coartem Drug: artesunate-lapdap |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Non-Inferiority, Open-Labelled, Randomised Trial Of The Efficacy And Safety Of Artesunate-Amodiaquine, Artemether-Lumefantrine, And Artesunate-Lapdap For Treatment Of Uncomplicated P. Falciparum Malaria Among Children In Ghana |
Estimated Enrollment: | 510 |
Study Start Date: | June 2005 |
Study Completion Date: | May 2006 |
Ages Eligible for Study: | 6 Months to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ghana, Brong Ahafo Region | |
Kintampo Health Research Centre | |
Kintampo, Brong Ahafo Region, Ghana |
Principal Investigator: | Seth Owusu-Agyei, PhD | London School of Hygiene & Tropical Medicine |
Principal Investigator: | Daniel Chandramohan, MBBS, PhD | London School of Hygiene & Tropical Medicine |
Principal Investigator: | Brian M Greenwood, FRCP, FRS | London School of Hygiene & Tropical Medicine |
Study ID Numbers: | ITDCVG44 |
Study First Received: | July 4, 2005 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00119145 |
Health Authority: | Ghana: Ministry of Health |
antimalarial drugs efficacy safety trial |
Benflumetol Artesunate Artemether-lumefantrine combination Protozoan Infections Amodiaquine |
Parasitic Diseases Malaria Artemether Malaria, Falciparum |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |