MedTrace Logo

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

NCT00493363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-05-04

No results posted yet for this study

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').

Conditions

  • Falciparum Malaria

Interventions

DRUG

Artesunate

Artesunate 2 mg/kg/day for 7 days

DRUG

Artesunate + Mefloquine

Artesunate 4mg/kg/day for 3 days plus mefloquine 15mg/kg on day 3 and 10mg/kg on day 4

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • NCHADS - Ministry of Health of Cambodia

    collaborator OTHER

  • Mahidol University

    collaborator OTHER

  • Institut Pasteur

    collaborator INDUSTRY

  • FHI 360

    collaborator OTHER

  • Li Ka Shing Foundation

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Nicholas J White, DSc,FRCP,FRS · Oxford University/ Mahidol University

  • Duong Socheat, MD · National Malaria Control Programme Cambodia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Cambodia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00493363 on ClinicalTrials.gov