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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR COARTEM

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Clinical Trials for Coartem

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.
NCT00153491 Adherence to Lumefantrine-Artemether Completed Ifakara Health Research and Development Centre Phase 4 This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
NCT00153491 Adherence to Lumefantrine-Artemether Completed Centers for Disease Control and Prevention Phase 4 This is a study of how well caregivers of children with malaria adhere to the recommended regimen for lumefantrine-artemether (LA). Children were randomly assigned to either a group receiving directly observed treatment in hospital or to a group treated at home by the routine caregiver (typically, patient's mother). Clinical/parasitologic, hematologic, pharmacologic and qualitative parameters were monitored over a 28-day follow-up period and are used to evaluate drug adherence.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Coartem

Condition Name

Condition Name for Coartem
Intervention Trials
Malaria 43
Malaria, Falciparum 8
Uncomplicated Malaria 3
HIV Infections 3
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Condition MeSH

Condition MeSH for Coartem
Intervention Trials
Malaria 57
Malaria, Falciparum 22
HIV Infections 4
Infection 2
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Clinical Trial Locations for Coartem

Trials by Country

Trials by Country for Coartem
Location Trials
Kenya 10
Tanzania 8
Uganda 8
Mozambique 8
Congo, The Democratic Republic of the 7
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Trials by US State

Trials by US State for Coartem
Location Trials
California 1
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Clinical Trial Progress for Coartem

Clinical Trial Phase

Clinical Trial Phase for Coartem
Clinical Trial Phase Trials
Phase 4 30
Phase 3 15
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Coartem
Clinical Trial Phase Trials
Completed 48
Not yet recruiting 4
Recruiting 4
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Clinical Trial Sponsors for Coartem

Sponsor Name

Sponsor Name for Coartem
Sponsor Trials
London School of Hygiene and Tropical Medicine 11
Centers for Disease Control and Prevention 10
Gates Malaria Partnership 5
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Sponsor Type

Sponsor Type for Coartem
Sponsor Trials
Other 130
U.S. Fed 13
Industry 10
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