NCT00298610

Safety and Efficacy Study of IV Artesunate to Treat Malaria

A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.

Detailed description

This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Artesunate	Intravenous Artesunate (2.4 mg/kg) once a day for three days
DRUG	Malarone	(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-03-02
• Last updated: 2019-10-01
• Results posted: 2017-03-22

Locations

1 site across 1 country: Kenya