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CompletedNCT00459615Updated Sep 25, 2008

Phase II Dose Ranging Study of Artesunate

A Phase 2 interventional study of Artesunate for Injection in Falciparum Malaria and Uncomplicated Malaria, sponsored by U.S. Army Office of the Surgeon General. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-09-25.

Sponsored by U.S. Army Office of the Surgeon General · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
12 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 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.

02

Conditions studied

  • Falciparum Malaria
  • Uncomplicated Malaria

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03

In context

Malaria, Falciparum

390 studies on the registry are indexed under Malaria, Falciparum; 35 are open to participants now.

This study's planned enrollment of 120 is close to the median of 127 across 325 interventional studies indexed under Malaria, Falciparum.

Browse Malaria, Falciparum studies →

Lead sponsor

U.S. Army Office of the Surgeon General is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
120 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. The primary endpoint for this pharmacodynamic study is clearance of falciparum parasites from the blood.

  2. Reference microscopic interpretation of Giemsa-stained thick and thin blood smears for malaria will serve as the diagnostic method of parasitemia detection.

  3. Parasite clearance will be quantified using a discrete variable denoting efficacy to clear at least 90% of asexual parasites from the peripheral blood by 48 hours after administration of IV artesunate

Secondary outcomes

  1. Additional measures of parasite clearance will also be assessed.

  2. A continuous variable of time to parasite reduction milestones:

  3. parasite clearance time (PCT90 and PCT100), and parasite reduction ratios (PRR12h and PRR24h) at defined time points , and

  4. A continuous variable of area under the curve (AUC) of quantifiable parasitemia

  5. Tolerability of the treatment regimens will also be assessed throughout the study through use of evaluation for adverse events and safety laboratories to include hematology and chemistry tests.

07

Study locations

2 sites
  • New Nyanza Provincial Hospital
    Kisumu, Nyanza, Kenya
  • Kwai River Christian Hospital
    Sangkhla Buri, Kanchanaburi, Thailand
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2007, a primary completion of Dec 2007 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2007
First posted
Apr 12, 2007
Start
Apr 2007
Primary completionActual
Dec 2007
CompletionActual
Jan 2008
Last update
Sep 25, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00459615
Lead sponsor
U.S. Army Office of the Surgeon General
Collaborators
Military Infectious Diseases Research Program (MIDRP), U.S. Army Medical Research and Development Command
First posted
Apr 12, 2007
Start date
Apr 2007
Primary completion
Dec 2007
Completion
Jan 2008
Last update
Sep 25, 2008

Study contacts

Mark Polhemus, MD
principal investigator · USAMRU-K
Bryan Smith, MD
principal investigator · Armed Forces Research Institute of Medical Sciences, Thailand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Artesunate

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