NCT00459615

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

April 10, 2007

Last Update Submit

September 23, 2008

Conditions

Falciparum MalariaUncomplicated Malaria

Outcome Measures

Primary Outcomes (3)

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

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

  • 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 (5)

  • Additional measures of parasite clearance will also be assessed.

  • A continuous variable of time to parasite reduction milestones:

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

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

  • 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.

Interventions

Artesunate for InjectionDRUG

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New Nyanza Provincial Hospital

Kisumu, Nyanza, Kenya

Location

Kwai River Christian Hospital

Sangkhla Buri, Kanchanaburi, Thailand

Location

Related Links

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

ArtesunateInjections

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Mark Polhemus, MD

    USAMRU-K

    PRINCIPAL INVESTIGATOR

  • Bryan Smith, MD

    Armed Forces Research Institute of Medical Sciences, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 12, 2007

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

KE(1)TH(1)