Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
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').
Phase:
N/A
Details
Lead Sponsor:
University of Oxford
Collaborators:
FHI 360 Institut Pasteur Li Ka Shing Foundation Mahidol University NCHADS - Ministry of Health of Cambodia World Health Organization