Status:
COMPLETED
Phase II Dose Ranging Study of Artesunate
Lead Sponsor:
U.S. Army Office of the Surgeon General
Collaborating Sponsors:
Military Infectious Diseases Research Program (MIDRP)
U.S. Army Medical Research and Development Command
Conditions:
Falciparum Malaria
Uncomplicated Malaria
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Acute symptomatic Plasmodium falciparum malaria infection as determined by malaria smear with a parasite density of ≥ 5000 asexual parasites/mL
- Age: 5-65 year old males and females.
- Written informed consent must be obtained from adults age \> 18 years. Parental consent will be obtained from children and adolescents, and subject assent will also be obtained from adolescents (age 12-17 years).
- Willing to stay hospitalized for 4 days for treatment and for 3 scheduled follow-up outpatient visits at Day 7, 14 and 28.
Exclusion
- Pregnant women (clinically or by positive urine β-HCG) and nursing mothers
- Clinical evidence of severe malaria (see Appendix B)
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drug artesunate or other artemisinin derivatives or Malarone.
- Efficacious malaria drug therapy administered in the past 30 days by history (i.e. quinine, mefloquine, lumefantrine and artemisinin derivatives)
- Previous participation in this trial or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study.
- Laboratory evidence or a history of significant liver or renal functional abnormality.
- Anyone who has received a transfusion or any blood product within 30 days
- Unable and/or unlikely to comprehend and/or follow the protocol.
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00459615
Start Date
April 1 2007
End Date
January 1 2008
Last Update
September 25 2008
Active Locations (2)
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1
New Nyanza Provincial Hospital
Kisumu, Nyanza, Kenya
2
Kwai River Christian Hospital
Sangkhla Buri, Kanchanaburi, Thailand