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Last Updated: January 16, 2021

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CLINICAL TRIALS PROFILE FOR COARTEM

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505(b)(2) Clinical Trials for Coartem

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00694694 Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed National Institute for Medical Research, Tanzania Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination NCT00694694 Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed London School of Hygiene and Tropical Medicine Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination NCT01899820 Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya Unknown status Kenya Medical Research Institute Phase 3 2013-04-01 Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs. This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice. Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including - Working towards the standardization of methodologies and common protocols as a way of comparing data across sites - Pulling together datasets and conduct a multi-centre analysis - Sharing and coordinating quality assurance mechanisms
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Coartem

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00118794 Lapdap and Coartemether for Uncomplicated Malaria Completed Medical Research Council Phase 3 2004-09-01 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 2004-09-01 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 2004-09-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Coartem

Condition Name

Condition Name for Coartem
Intervention Trials
Malaria 48
Malaria, Falciparum 8
Plasmodium Falciparum Malaria 5
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Condition MeSH

Condition MeSH for Coartem
Intervention Trials
Malaria 67
Malaria, Falciparum 28
HIV Infections 4
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Clinical Trial Locations for Coartem

Trials by Country

Trials by Country for Coartem
Location Trials
Mozambique 13
Congo, The Democratic Republic of the 13
Kenya 11
Tanzania 8
Uganda 8
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Trials by US State

Trials by US State for Coartem
Location Trials
California 2
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Clinical Trial Progress for Coartem

Clinical Trial Phase

Clinical Trial Phase for Coartem
Clinical Trial Phase Trials
Phase 4 37
Phase 3 16
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Coartem
Clinical Trial Phase Trials
Completed 54
Not yet recruiting 9
Terminated 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 13
Centers for Disease Control and Prevention 11
Kenya Medical Research Institute 5
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Sponsor Type

Sponsor Type for Coartem
Sponsor Trials
Other 165
U.S. Fed 16
Industry 12
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