Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
There are worrying signs that parasitological responses to the artemisinin drugs for uncomplicated falciparum malaria are slower than elsewhere in the world.If responses to artesunate are poor it is essential to have characterised the blood concentration profile as well as the parasitological response to differentiate resistance from abnormal pharmacokinetics.
The primary objective of the study is to assess the level of resistance to artemisinin derivatives in Western Cambodia.
A detailed evaluation of 2 different artesunate containing regimens in patients with uncomplicated malaria will be performed. Patients will be randomised to receive either a) Artesunate 2mg/kg/day for 7 days or b) Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4 The effect on parasite clearance and cure will be assessed in relation to blood concentrations of the antimalarial drugs ('PK-PD').
Drug: artesunate 2 mg/kg/day versus 4 mg/kg/day icm mefloquine
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia|
- parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) [ Time Frame: June 2008 ]
- 56 day cure rates, in vitro sensitivity, molecular markers of drug resistance [ Time Frame: June 2008 ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493363
|Pailin Referal Hospital|
|Principal Investigator:||Nicholas J White, DSc,FRCP,FRS||Oxford University/ Mahidol University|
|Study Chair:||Duong Socheat, MD||National Malaria Control Programme Cambodia|