NCT00459615

Phase II Dose Ranging Study of Artesunate

A Phase II, Randomized, Open-Label, Dose-Ranging Study of Intravenous Artesunate Therapy for the Treatment of Acute, Uncomplicated Plasmodium Falciparum Malaria.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: U.S. Army Office of the Surgeon General · Federal
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To compare the efficacy and tolerability of intravenous artesunate for the initial treatment of uncomplicated Plasmodium falciparum malaria at doses that bracket anticipated clinical doses (2.4 mg/kg once daily for 3 days; or 2.4 mg/kg initially, at 12 hours on Day 0, and then daily on Day 1 and 2) and thereby establish the safest, highly efficacious dosing regimen for use in future clinical trials.

Conditions

• Falciparum Malaria
• Uncomplicated Malaria

Interventions

Type	Name	Description
DRUG	Artesunate for Injection

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2007-04-12
• Last updated: 2008-09-25

Locations

2 sites across 2 countries: Kenya, Thailand