Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Artemisinins; Artesunate; Mefloquine

Criteria

Inclusion Criteria:

• Children >5yrs and adults presenting with acute falciparum malaria (N=40) to Pailin hospital will be eligible for inclusion in this study provided that

• They or their parents/guardians give fully informed consent.

• They are not pregnant.

• They have not received antimalarial drugs in the previous 48 hours.

• P.falciparum parasitaemia exceeds 10,000/uL

Exclusion Criteria:

• Mixed infection (such as vivax malaria), history of allergy to artesunate or mefloquine, any sign of severe disease according to WHO criteria