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Artemisinin Resistance in Cambodia II (ARC II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722150
First Posted: July 25, 2008
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
World Health Organization
Bill and Melinda Gates Foundation
Information provided by:
Armed Forces Research Institute of Medical Sciences, Thailand
  Purpose

The purpose of this study is to determine the impact of varying doses of artesunate on treatment outcome and whether higher doses of artesunate can overcome the problem of compromised artemisinin sensitivity in the region.

To determine the safety and tolerability of this previously untested experimental high dose (6 mg/Kg/D X 7 day, total 42 mg/Kg) artesunate monotherapy regimen.


Condition Intervention
Falciparum Malaria Drug: Artesunate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artemisinin Resistance in Cambodia II

Resource links provided by NLM:


Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:

Primary Outcome Measures:
  • Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR as defined by WHO criteria) on Day 28 and 42 [ Time Frame: Day 28 and 42 ]
  • Safety and tolerability of oral artesunate [ Time Frame: Up to 42 days ]

Secondary Outcome Measures:
  • Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). [ Time Frame: Day 3 ]

Enrollment: 143
Study Start Date: July 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Oral Artesunate ("standard" dose)
Drug: Artesunate
2 mg/kg/day x 7 days
Active Comparator: Arm 2
Oral Artesunate ("ARC1" dose)
Drug: Artesunate
4 mg/kg/day x 7 days
Experimental: Arm 3
Oral Artesunate (experimental "high" dose)
Drug: Artesunate
6 mg/kg/day x 7 days

Detailed Description:

A total of 150 volunteers with acute uncomplicated falciparum malaria will be randomly assigned one of 3 arms to be treated with artesunate monotherapy for 7 days at a ratio of 2:1:2.

Arm 2 serves as a control and will serve as a bridge to the ARC 1 study performed in 2006/2007. Patients in Arm 1 will receive a relatively low "standard" dose, and patients in Arm 2 will receive the intermediate dose of 4 mg/kg that was used in the ARC1 study. Patients in Arm 3 will receive an experimental "high-dose" regimen. Currently available safety data extends to subjects who have received the 28 mg/Kg total dose over 7 days and to another study administering 8 mg/Kg/day for 3 days (total dose 24 mg/Kg). Subjects randomized into this study's 'high-dose' Arm 3 will, therefore, receive a total dose that is higher than has been previously studied in humans.

The study design will be based on the WHO recommendations for the 'Assessment and Monitoring of Antimalarial Drug Efficacy for the Treatment of Uncomplicated Falciparum Malaria' (WHO, 2003).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 1000 to 200,000 asexual parasites/Micro-liter as determined on the thick/thin screening smear with fever (defined as ≥ 37.5ºC), or reported history of fever within the last 48 hours.
  2. Age: 18-65 years old
  3. All females between the age of 18 and 50 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, or oral contraceptive(s), if possible with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study.
  4. Written informed consent obtained
  5. Willing to stay under close medical supervision for the study duration of 42 days
  6. Otherwise healthy Out-patients

Exclusion Criteria:

  1. Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, # 3)
  2. Mixed malaria infection on admission by malaria smear
  3. A previous history of intolerance or hypersensitivity to the study drug artesunate or to drugs with similar chemical structures, such as artemether, artemisinin or dihydroartemisinin
  4. History of malaria drug therapy administered in the past 30 days
  5. 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
  6. 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.
  7. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
  8. Signs or symptoms of severe malaria (adapted from WHO recommendations (2003): prostration, impaired consciousness, respiratory distress, convulsions, systolic blood pressure < 70 mm Hg, abnormal bleeding, severe anemia with hemoglobin < 8 g/dL or HCT < 24%, hyperparasitemia at > 4% parasitized red blood cells).
  9. Unable and/or unlikely to comprehend and/or follow the protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722150


Locations
Cambodia
Tasanh Health Center
Sam Lot District, Battambang, Cambodia
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
World Health Organization
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Delia Bethell, BM BCh Armed Forces Research Institute of Medical Sciences (AFRIMS)
Principal Investigator: Socheat Duong, M.D. National Center for Parasitology, Entomology and Malaria Control
Principal Investigator: Se Youry, M.D., M.P.H.M. Armed Forces Research Institute of Medical Sciences (AFRIMS)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Fukuda, M.D., LTC, MC, Armed Forces Research Institute of Medical Sciences (AFRIMS)
ClinicalTrials.gov Identifier: NCT00722150     History of Changes
Other Study ID Numbers: WRAIR 1396
HSRRB number A-14479
WHO RPC252
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
Artesunate
Plasmodium Falciparum
Cambodia

Additional relevant MeSH terms:
Malaria, Falciparum
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Artemisinine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials