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Phase II Dose Ranging Study of Artesunate

NCT00459615 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-09-25

No results posted yet for this study

Summary

The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy.

Conditions

  • Falciparum Malaria
  • Uncomplicated Malaria

Interventions

DRUG

Artesunate for Injection

Sponsors & Collaborators

  • Military Infectious Diseases Research Program (MIDRP)

    collaborator NETWORK

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • U.S. Army Office of the Surgeon General

    lead FED

Principal Investigators

  • Mark Polhemus, MD · USAMRU-K

  • Bryan Smith, MD · Armed Forces Research Institute of Medical Sciences, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-12-31
Completion
2008-01-31

Countries

  • Kenya
  • Thailand

Study Locations

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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 NCT00459615 on ClinicalTrials.gov