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Artemisinin Resistance in Cambodia II

NCT00722150 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2011-01-25

No results posted yet for this study

Summary

The purpose of this study is to determine the impact of varying doses of artesunate on treatment outcome and whether higher doses of artesunate can overcome the problem of compromised artemisinin sensitivity in the region.

To determine the safety and tolerability of this previously untested experimental high dose (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.

Conditions

  • Falciparum Malaria

Interventions

DRUG

Artesunate

2 mg/kg/day x 7 days

DRUG

Artesunate

4 mg/kg/day x 7 days

DRUG

Artesunate

6 mg/kg/day x 7 days

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Armed Forces Research Institute of Medical Sciences, Thailand

    lead OTHER_GOV

Principal Investigators

  • Delia Bethell, BM BCh · Armed Forces Research Institute of Medical Sciences (AFRIMS)

  • Socheat Duong, M.D. · National Center for Parasitology, Entomology and Malaria Control

  • Se Youry, M.D., M.P.H.M. · Armed Forces Research Institute of Medical Sciences (AFRIMS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Cambodia

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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 NCT00722150 on ClinicalTrials.gov