Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
143 participants
INTERVENTIONAL
2008-07-31
2009-08-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Oral Artesunate ("standard" dose)
Artesunate
2 mg/kg/day x 7 days
Arm 2
Oral Artesunate ("ARC1" dose)
Artesunate
4 mg/kg/day x 7 days
Arm 3
Oral Artesunate (experimental "high" dose)
Artesunate
6 mg/kg/day x 7 days
Interventions
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Artesunate
2 mg/kg/day x 7 days
Artesunate
4 mg/kg/day x 7 days
Artesunate
6 mg/kg/day x 7 days
Eligibility Criteria
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Inclusion Criteria
2. Age: 18-65 years old
3. All females between the age of 18 and 50 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, or oral contraceptive(s), if possible with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study.
4. Written informed consent obtained
5. Willing to stay under close medical supervision for the study duration of 42 days
6. Otherwise healthy Out-patients
2. Mixed malaria infection on admission by malaria smear
3. A previous history of intolerance or hypersensitivity to the study drug artesunate or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin
4. History of malaria drug therapy administered in the past 30 days
5. Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
7. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
8. Signs or symptoms of severe malaria (adapted from WHO recommendations (2003): prostration, impaired consciousness, respiratory distress, convulsions, systolic blood pressure \< 70 mm Hg, abnormal bleeding, severe anemia with hemoglobin \< 8 g/dL or HCT \< 24%, hyperparasitemia at \> 4% parasitized red blood cells).
9. Unable and/or unlikely to comprehend and/or follow the protocol
18 Years
65 Years
ALL
No
Sponsors
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World Health Organization
OTHER
Bill and Melinda Gates Foundation
OTHER
Armed Forces Research Institute of Medical Sciences, Thailand
OTHER_GOV
Responsible Party
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Armed Forces Research Institute of Medical Sciences (AFRIMS)
Principal Investigators
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Delia Bethell, BM BCh
Role: PRINCIPAL_INVESTIGATOR
Armed Forces Research Institute of Medical Sciences (AFRIMS)
Socheat Duong, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Center for Parasitology, Entomology and Malaria Control
Se Youry, M.D., M.P.H.M.
Role: PRINCIPAL_INVESTIGATOR
Armed Forces Research Institute of Medical Sciences (AFRIMS)
Locations
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Tasanh Health Center
Sam Lot District, Battambang, Cambodia
Countries
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References
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Bethell D, Se Y, Lon C, Tyner S, Saunders D, Sriwichai S, Darapiseth S, Teja-Isavadharm P, Khemawoot P, Schaecher K, Ruttvisutinunt W, Lin J, Kuntawungin W, Gosi P, Timmermans A, Smith B, Socheat D, Fukuda MM. Artesunate dose escalation for the treatment of uncomplicated malaria in a region of reported artemisinin resistance: a randomized clinical trial. PLoS One. 2011;6(5):e19283. doi: 10.1371/journal.pone.0019283. Epub 2011 May 13.
Bethell D, Se Y, Lon C, Socheat D, Saunders D, Teja-Isavadharm P, Khemawoot P, Darapiseth S, Lin J, Sriwichai S, Kuntawungin W, Surasri S, Lee SJ, Sarim S, Tyner S, Smith B, Fukuda MM. Dose-dependent risk of neutropenia after 7-day courses of artesunate monotherapy in Cambodian patients with acute Plasmodium falciparum malaria. Clin Infect Dis. 2010 Dec 15;51(12):e105-14. doi: 10.1086/657402. Epub 2010 Nov 11.
Other Identifiers
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HSRRB number A-14479
Identifier Type: -
Identifier Source: secondary_id
WHO RPC252
Identifier Type: -
Identifier Source: secondary_id
WRAIR 1396
Identifier Type: -
Identifier Source: org_study_id
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