NCT00479206

Brief Summary

The principal aim of this project is to investigate reports of developing artemisinin resistance in Cambodia using an integrated in vivo - in vitro approach to examine recent alarming reports of treatment failures with advanced combination therapies along the Thai-Cambodian border, which could have major impact on the malaria situation in the affected areas as well as the rest of the malaria-endemic world.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
Last Updated

April 30, 2008

Status Verified

April 1, 2008

First QC Date

May 25, 2007

Last Update Submit

April 29, 2008

Conditions

Malaria, Falciparum

Keywords

artesuantefalciparum malariaCambodiaArtemisinin resistance

Outcome Measures

Primary Outcomes (1)

  • Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR as defined by WHO criteria) on Day 28.

Secondary Outcomes (1)

  • Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT).

Interventions

ArtesunateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as \>=37.5ºC), or reported history of fever within the last 48 hours.
  • Age: 18-65 years old
  • Males or females. All females are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
  • Written informed consent obtained
  • Willing to stay under close medical supervision for the study duration of 28 days
  • Otherwise healthy outpatients

You may not qualify if:

  • Mixed malaria infection on admission by malaria smear
  • A previous history of intolerance or hypersensitivity to the study drugs artesunate, quinine, or tetracycline or to drugs with similar chemical structures (quinidine, any artemisinin derivative, and tetracyclines)
  • Malaria drug therapy administered in the past 30 days by history
  • 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
  • History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
  • Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
  • Signs or symptoms of severe malaria (as defined by WHO 2003)
  • Unable and/or unlikely to comprehend and/or follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tasanh Health Center

Tasanh, Battambang, Cambodia

Location

Related Publications (1)

  • Noedl H, Se Y, Sriwichai S, Schaecher K, Teja-Isavadharm P, Smith B, Rutvisuttinunt W, Bethell D, Surasri S, Fukuda MM, Socheat D, Chan Thap L. Artemisinin resistance in Cambodia: a clinical trial designed to address an emerging problem in Southeast Asia. Clin Infect Dis. 2010 Dec 1;51(11):e82-9. doi: 10.1086/657120. Epub 2010 Oct 28.

    PMID: 21028985DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artesunate

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Harald Noedl, MD, MCTM, PhD

    USAMC-AFRIMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2007

First Posted

May 28, 2007

Study Start

October 1, 2006

Study Completion

February 1, 2007

Last Updated

April 30, 2008

Record last verified: 2008-04

Locations

CA(1)