Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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
- 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
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
No publications provided by University of Oxford
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Arjen Dondorp, Mahidol Oxford Research Unit |
| ClinicalTrials.gov Identifier: | NCT00493363 History of Changes |
| Other Study ID Numbers: | 1-Dondorp |
| Study First Received: | June 27, 2007 |
| Last Updated: | January 21, 2010 |
| Health Authority: | Cambodia: Ministry of Health United Kingdom: Research Ethics Committee |
Keywords provided by University of Oxford:
|
falciparum malaria artemisinins artesunate resistance |
Additional relevant MeSH terms:
|
Disease Susceptibility Genetic Predisposition to Disease Malaria Malaria, Falciparum Disease Attributes Pathologic Processes Protozoan Infections Parasitic Diseases Mefloquine |
Artesunate Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Amebicides |
ClinicalTrials.gov processed this record on May 21, 2013