Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459615
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2007-04-10
Brief Title:
Phase II Dose Ranging Study of Artesunate
Sponsor:
US Army Office of the Surgeon General
Organization:
Walter Reed Army Institute of Research WRAIR
Study Overview
Official Title:
A Phase II Randomized Open-Label Dose-Ranging Study of Intravenous Artesunate Therapy for the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 24 mgkg once daily for 3 days or 24 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSRRB Protocol LogA-13912ab | None | None | None |