Artemisinin Resistance in Cambodia II (ARC II)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Artemisinin Resistance in Cambodia II|
- Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR as defined by WHO criteria) on Day 28 and 42 [ Time Frame: Day 28 and 42 ] [ Designated as safety issue: No ]
- Safety and tolerability of oral artesunate [ Time Frame: Up to 42 days ] [ Designated as safety issue: Yes ]
- Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
Oral Artesunate ("standard" dose)
2 mg/kg/day x 7 days
Active Comparator: Arm 2
Oral Artesunate ("ARC1" dose)
4 mg/kg/day x 7 days
Experimental: Arm 3
Oral Artesunate (experimental "high" dose)
6 mg/kg/day x 7 days
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722150
|Tasanh Health Center|
|Sam Lot District, Battambang, Cambodia|
|Principal Investigator:||Delia Bethell, BM BCh||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)|