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| Sponsors and Collaborators: |
University of Oxford World Health Organization NCHADS - Ministry of Health of Cambodia Mahidol University Institut Pasteur Family Health International Li Ka Shing Foundation |
|---|---|
| Information provided by: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00493363 |
Purpose
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 | Intervention |
|---|---|
|
Falciparum Malaria |
Drug: artesunate 2 mg/kg/day versus 4 mg/kg/day icm mefloquine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Clinical Investigation of in-Vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Study Completion Date: | May 2008 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
Contacts and Locations| Cambodia | |
| Pailin Referal Hospital | |
| Pailin, Cambodia | |
| Principal Investigator: | Nicholas J White, DSc,FRCP,FRS | Oxford University/ Mahidol University |
| Study Chair: | Duong Socheat, MD | National Malaria Control Programme Cambodia |
More Information
| Study ID Numbers: | 1-Dondorp |
| Study First Received: | June 27, 2007 |
| Last Updated: | October 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00493363 |
| Health Authority: | Cambodia: Ministry of Health; United Kingdom: Research Ethics Committee |
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falciparum malaria artemisinins artesunate resistance |
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Artesunate Protozoan Infections Artemisinins Disease Susceptibility Artemisinine |
Parasitic Diseases Malaria Mefloquine Genetic Predisposition to Disease Malaria, Falciparum |
|
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Disease Attributes |
Pathologic Processes Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |
