Phase II Dose Ranging Study of Artesunate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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

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Falciparum Malaria Uncomplicated Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Artesunate for Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Acute symptomatic Plasmodium falciparum malaria infection as determined by malaria smear with a parasite density of ≥ 5000 asexual parasites/mL
2. Age: 5-65 year old males and females.
3. 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).
4. Willing to stay hospitalized for 4 days for treatment and for 3 scheduled follow-up outpatient visits at Day 7, 14 and 28.

Exclusion Criteria

1. Pregnant women (clinically or by positive urine β-HCG) and nursing mothers
2. Clinical evidence of severe malaria (see Appendix B)
3. Mixed malaria infection on admission by malaria smear
4. A previous history of intolerance or hypersensitivity to the study drug artesunate or other artemisinin derivatives or Malarone.
5. Efficacious malaria drug therapy administered in the past 30 days by history (i.e. quinine, mefloquine, lumefantrine and artemisinin derivatives)
6. 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.
7. Laboratory evidence or a history of significant liver or renal functional abnormality.
8. Anyone who has received a transfusion or any blood product within 30 days
9. Unable and/or unlikely to comprehend and/or follow the protocol.
10. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Mark Polhemus, MD

Role: PRINCIPAL_INVESTIGATOR

USAMRU-K

Bryan Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Armed Forces Research Institute of Medical Sciences, Thailand

Locations

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New Nyanza Provincial Hospital

Kisumu, Nyanza, Kenya

Site Status

Kwai River Christian Hospital

Sangkhla Buri, Kanchanaburi, Thailand

Site Status

Countries

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Kenya Thailand

Other Identifiers

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HSRRB Protocol Log#A-13912a,b

Identifier Type: -

Identifier Source: secondary_id

WRAIR 1263