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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ARTEMETHER; LUMEFANTRINE

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Clinical Trials for Artemether; Lumefantrine

Trial ID Title Status Sponsor Phase Summary
NCT00118794 Lapdap and Coartemether for Uncomplicated Malaria Completed Medical Research Council Phase 3 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 Lapdap and Coartemether for Uncomplicated Malaria Completed National Malaria Control Programme, The Gambia Phase 3 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 Lapdap and Coartemether for Uncomplicated Malaria Completed London School of Hygiene and Tropical Medicine Phase 3 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00119145 Kintampo Trial of Combination Therapy for Malaria Completed Kintampo Health Research Centre, Ghana Phase 4 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.
NCT00119145 Kintampo Trial of Combination Therapy for Malaria Completed Gates Malaria Partnership Phase 4 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.
NCT00127998 Antimalarial Drug Resistance in Mali Completed Malaria Research and Training Center, Bamako, Mali N/A Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Artemether; Lumefantrine

Condition Name

Condition Name for Artemether; Lumefantrine
Intervention Trials
Malaria 78
Malaria, Falciparum 14
HIV Infections 7
Plasmodium Falciparum Malaria 5
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Condition MeSH

Condition MeSH for Artemether; Lumefantrine
Intervention Trials
Malaria 119
Malaria, Falciparum 43
HIV Infections 8
Malaria, Vivax 6
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Clinical Trial Locations for Artemether; Lumefantrine

Trials by Country

Trials by Country for Artemether; Lumefantrine
Location Trials
Tanzania 21
Kenya 18
Burkina Faso 14
Uganda 13
Mozambique 12
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Trials by US State

Trials by US State for Artemether; Lumefantrine
Location Trials
California 2
Maryland 1
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Clinical Trial Progress for Artemether; Lumefantrine

Clinical Trial Phase

Clinical Trial Phase for Artemether; Lumefantrine
Clinical Trial Phase Trials
Phase 4 59
Phase 3 33
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Artemether; Lumefantrine
Clinical Trial Phase Trials
Completed 91
Recruiting 15
Unknown status 12
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Clinical Trial Sponsors for Artemether; Lumefantrine

Sponsor Name

Sponsor Name for Artemether; Lumefantrine
Sponsor Trials
London School of Hygiene and Tropical Medicine 17
Centers for Disease Control and Prevention 15
University of Oxford 12
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Sponsor Type

Sponsor Type for Artemether; Lumefantrine
Sponsor Trials
Other 309
Industry 30
U.S. Fed 22
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Accenture

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