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

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ClinicalTrials.gov Identifier: NCT00493363
Recruitment Status : Completed
First Posted : June 28, 2007
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
World Health Organization
NCHADS - Ministry of Health of Cambodia
Mahidol University
Institut Pasteur
FHI 360
Li Ka Shing Foundation
Information provided by (Responsible Party):
Arjen Dondorp, University of Oxford

Brief 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').


Condition or disease Intervention/treatment Phase
Falciparum Malaria Drug: Artesunate Drug: Artesunate + Mefloquine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arm Intervention/treatment
Experimental: arm 1 Drug: Artesunate
Artesunate 2 mg/kg/day for 7 days
Active Comparator: arm 2 Drug: Artesunate + Mefloquine
Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4



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


Secondary Outcome Measures :
  1. 56 day cure rates, in vitro sensitivity, molecular markers of drug resistance [ Time Frame: June 2008 ]
    56 day cure rates, in vitro sensitivity, molecular markers of drug resistance



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arjen Dondorp, Deputy Director, University of Oxford
ClinicalTrials.gov Identifier: NCT00493363     History of Changes
Other Study ID Numbers: 1-Dondorp
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Arjen Dondorp, University of Oxford:
falciparum malaria
artemisinins
artesunate
resistance

Additional relevant MeSH terms:
Malaria
Disease Susceptibility
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Disease Attributes
Pathologic Processes
Artesunate
Artemisinins
Mefloquine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials