Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
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|ClinicalTrials.gov Identifier: NCT00493363|
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : May 4, 2018
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').
|Condition or disease||Intervention/treatment||Phase|
|Falciparum Malaria||Drug: Artesunate Drug: Artesunate + Mefloquine||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
|Experimental: arm 1||
Artesunate 2 mg/kg/day for 7 days
|Active Comparator: arm 2||
Drug: Artesunate + Mefloquine
Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4
- parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) [ Time Frame: June 2008 ]parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD)
- 56 day cure rates, in vitro sensitivity, molecular markers of drug resistance [ Time Frame: June 2008 ]56 day cure rates, in vitro sensitivity, molecular markers of drug resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|