CLINICAL TRIALS PROFILE FOR ARTESUNATE

505(b)(2) Clinical Trials for ARTESUNATE

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	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.

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.

Clinical Trial Conditions for ARTESUNATE

Condition Name

Condition Name for ARTESUNATE
Intervention	Trials
Malaria	102
Malaria, Falciparum	17
Falciparum Malaria	12
Plasmodium Falciparum Malaria	10

Condition MeSH

Condition MeSH for ARTESUNATE
Intervention	Trials
Malaria	191
Malaria, Falciparum	83
Malaria, Vivax	15
Carcinoma in Situ	4

Clinical Trial Locations for ARTESUNATE

Trials by Country

Trials by Country for ARTESUNATE
Location	Trials
Mozambique	28
Burkina Faso	23
Congo, The Democratic Republic of the	23
Thailand	22
Kenya	18

Trials by US State

Trials by US State for ARTESUNATE
Location	Trials
Maryland	6
Kentucky	2
Ohio	2
California	2
Texas	1

Clinical Trial Progress for ARTESUNATE

Clinical Trial Phase

Clinical Trial Phase for ARTESUNATE
Clinical Trial Phase	Trials
Phase 4	61
Phase 3	50
Phase 2/Phase 3	12

Clinical Trial Status

Clinical Trial Status for ARTESUNATE
Clinical Trial Phase	Trials
Completed	161
Not yet recruiting	15
Recruiting	15

Clinical Trial Sponsors for ARTESUNATE

Sponsor Name

Sponsor Name for ARTESUNATE
Sponsor	Trials
London School of Hygiene and Tropical Medicine	26
University of Oxford	24
Medicines for Malaria Venture	17

Sponsor Type

Sponsor Type for ARTESUNATE
Sponsor	Trials
Other	478
Industry	52
U.S. Fed	36