Falciparum Malaria Clinical Trial
Official title:
Artemisinin Resistance in Cambodia 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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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