At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
Artesunate +1 moredrug
Likely dose
Intravenous artesunate 2.4 mg/kg once daily for 3 daysAI-extracted
Key inclusion· 4
- ✓Age 18–65 years, male or non-pregnant female
- ✓Fever (>37.5°C currently or within last 48 hours)
- ✓Confirmed falciparum malaria with parasitemia ≥200/µL
- ✓Able to comply with study requirements including admission and follow-up
Key exclusion· 10
- ✕Severe falciparum malaria (WHO definition)
- ✕Mixed malaria infection (non-falciparum co-infection)
- ✕Investigational drug use within 16 weeks prior
- ✕Recent medication use: prescription drugs within 14 days or OTC drugs within 5 days (with exceptions)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open Label, Study of the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Artesunate in Adults With Uncomplicated Malaria
U.S. Army Medical Research and Development Command·interventional·Posted Mar 2, 2006·Updated Oct 1, 2019
In Brief
A Phase 2 clinical trial evaluating Artesunate and Malarone for Malaria. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMar 2006
Primary CompletionOct 2007
TodayJul 2026
First PostedMar 2, 2006
Enrollment StartMar 1, 2006
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.3 years ago
Interventions
Artesunatedrug
Intravenous Artesunate (2.4 mg/kg) once a day for three days
Malaronedrug
(proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)