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Sponsors and Collaborators: |
Armed Forces Research Institute of Medical Sciences World Health Organization Bill and Melinda Gates Foundation |
Information provided by: | Armed Forces Research Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00722150 |
The purpose of this study is to determine the impact of varying doses of artesunate on treatment outcome and whether higher doses of artesunate can overcome the problem of compromised artemisinin sensitivity in the region.
To determine the safety and tolerability of this previously untested experimental high dose (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.
Condition | Intervention |
Falciparum Malaria |
Drug: Artesunate |
MedlinePlus related topics: | Malaria |
Drug Information available for: | Artesunate Artemisinin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Artemisinin Resistance in Cambodia II |
Estimated Enrollment: | 150 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm 1: Active Comparator
Oral Artesunate ("standard" dose) 2 mg/kg/day x 7 days (Total Dose = 14 mg/kg)
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Drug: Artesunate
2 mg/kg/day x 7 days
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Arm 2: Active Comparator
Oral Artesunate (ARC1 dose) 4 mg/kg/day x 7 days (Total Dose = 28 mg/kg)
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Drug: Artesunate
4 mg/kg/day x 7 days
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Arm 3: Experimental
Oral Artesunate (experimental "high" dose) 6 mg/kg/day x 7 days (Total Dose = 42 mg/kg)
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Drug: Artesunate
6 mg/kg/day x 7 days
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A total of 150 volunteers with acute uncomplicated falciparum malaria will be randomly assigned one of 3 arms to be treated with artesunate monotherapy for 7 days at a ratio of 2:1:2.
Arm 2 serves as a control and will serve as a bridge to the ARC 1 study performed in 2006/2007. Patients in Arm 1 will receive a relatively low "standard" dose, and patients in Arm 2 will receive the intermediate dose of 4 mg/kg that was used in the ARC1 study. Patients in Arm 3 will receive an experimental "high-dose" regimen. Currently available safety data extends to subjects who have received the 28 mg/Kg total dose over 7 days and to another study administering 8 mg/Kg/day for 3 days (total dose 24 mg/Kg). Subjects randomized into this study's 'high-dose' Arm 3 will, therefore, receive a total dose that is higher than has been previously studied in humans.
The study design will be based on the WHO recommendations for the 'Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria' (WHO, 2003).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sabaithip Sriwichai, RN | 662-644-5775 ext 2692 | sabaithips@afrims.org |
Contact: Chan Thap Lon, M.D., M.C.T.M. | 855 92 666 959 | chanthapl@afrims.org |
Cambodia, Battambang | |||||
Tasanh Health Center | |||||
Sam Lot District, Battambang, Cambodia |
Armed Forces Research Institute of Medical Sciences |
World Health Organization |
Bill and Melinda Gates Foundation |
Principal Investigator: | Mark Fukuda, M.D. | Armed Forces Research Institute of Medical Sciences (AFRIMS) |
Principal Investigator: | Socheat Duong, M.D. | National Center for Parasitology, Entomology and Malaria Control |
Principal Investigator: | Se Youry, M.D., M.P.H.M. | Armed Forces Research Institute of Medical Sciences (AFRIMS) |
Responsible Party: | Armed Forces Research Institute of Medical Sciences (AFRIMS) ( Mark Fukuda, M.D., LTC, MC ) |
Study ID Numbers: | WRAIR 1396, HSRRB number A-14479, WHO RPC252 |
First Received: | July 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00722150 |
Health Authority: | United States: Federal Government |
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