CLINICAL TRIALS PROFILE FOR ARTESUNATE
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505(b)(2) Clinical Trials for artesunate
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Combination | NCT00203801 ↗ | Combination Antimalarials in Uncomplicated Malaria | Completed | Global Fund | N/A | 2002-01-01 | The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine. |
| New Combination | NCT00203801 ↗ | Combination Antimalarials in Uncomplicated Malaria | Completed | Medical Research Council, South Africa | N/A | 2002-01-01 | The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine. |
| New Combination | NCT00203801 ↗ | Combination Antimalarials in Uncomplicated Malaria | Completed | World Health Organization | N/A | 2002-01-01 | The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine. |
| New Combination | NCT00203801 ↗ | Combination Antimalarials in Uncomplicated Malaria | Completed | University of Cape Town | N/A | 2002-01-01 | The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine. |
| 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 Formulation | NCT05140278 ↗ | Study to Compare Feasibility of 1-step Injectable Artesunate vs. Conventional 2-step Injectable Artesunate | Not yet recruiting | National Institute for Medical Research, Tanzania | Phase 2 | 2021-12-01 | The objectives of this study contains 3 parts: (1) a comparison of 1-step parenteral artesunate (AS) versus conventional 2-step parenteral artesunate in patients with severe malaria to assess the feasibility of administration, parasite and fever clearance times in two countries, (2) a quantification of convenience and costs of the new 1-step artesunate parenteral formulation versus the conventional formulation in a randomised study, (3) A cost analysis of 1-step parenteral artesunate using data from Part 1 & Part 2. This will assess health facility-level costs, and also health system costs to encompass all costs of a potential change from conventional to 1-step artesunate, including re-training, materials, and drug replacement. The conventional formulation of injectable artesunate requires a 2-step reconstitution and dilution of the artesunate hemisuccinate powder. A new formulation of injectable artesunate has been developed by Fosun Pharma requiring a simpler 1-step reconstitution. Bioequivalence of the new formulation to the conventional formulation. For part 1, a total number of participants of this study would be 200 participants, estimated 100 per site will be recruited. For part 2, a total number of 40 semi-structured interviews with study staff, health staff, policy makers, and stake holders; and survey/questionnaires with 150 health staff. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for artesunate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00111163 ↗ | Intermittent Preventive Treatment With Antimalarials in Kenyan Infants | Completed | Bill and Melinda Gates Foundation | N/A | 2004-03-01 | The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life. |
| NCT00111163 ↗ | Intermittent Preventive Treatment With Antimalarials in Kenyan Infants | Completed | Kenya Medical Research Institute | N/A | 2004-03-01 | The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life. |
| NCT00111163 ↗ | Intermittent Preventive Treatment With Antimalarials in Kenyan Infants | Completed | Centers for Disease Control and Prevention | N/A | 2004-03-01 | The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life. |
| NCT00118807 ↗ | Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children | Completed | Medical Research Council | Phase 3 | 2003-08-01 | The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose. |
| NCT00118807 ↗ | Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children | Completed | National Malaria Control Programme, The Gambia | Phase 3 | 2003-08-01 | The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose. |
| NCT00118807 ↗ | Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children | Completed | London School of Hygiene and Tropical Medicine | Phase 3 | 2003-08-01 | The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose. |
| NCT00119132 ↗ | Effectiveness of Intermittent Preventive Treatment for Malaria in Children | Completed | INDEPTH Network | Phase 2/Phase 3 | 2005-06-01 | Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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