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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
NCHADS - Ministry of Health of Cambodia
Mahidol University
Institut Pasteur
FHI 360
Li Ka Shing Foundation
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00493363
First received: June 27, 2007
Last updated: January 21, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • parasite clearance times in relation to artesunate/DHA plasma concentrations (PK-PD) [ Time Frame: June 2008 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493363

Locations
Cambodia
Pailin Referal Hospital
Pailin, Cambodia
Sponsors and Collaborators
University of Oxford
World Health Organization
NCHADS - Ministry of Health of Cambodia
Mahidol University
Institut Pasteur
FHI 360
Li Ka Shing Foundation
Investigators
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
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 August 21, 2014