Status:
COMPLETED
Artemisinin Resistance in Bangladesh
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
World Health Organization
Conditions:
Malaria
Eligibility:
All Genders
8-65 years
Phase:
NA
Brief Summary
A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
Detailed Description
A total number of 100 volunteers with acute uncomplicated falciparum malaria will be randomly assigned one of 3 arms to be treated with artesunate monotherapy or quinine/doxycycline for 7 days at a ra...
Eligibility Criteria
Inclusion
- Acute symptomatic falciparum malaria infection as determined by malaria smear with a parasite density of 1,000 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5C), or reported history of fever within the last 48 hours.
- Age: 8-65 years old
- All females between the age of 12 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 throughout the study
- Written informed consent obtained
- Willing to stay under close medical supervision for the study duration of 42 days
- Otherwise healthy outpatients
Exclusion
- Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception
- Mixed malaria infection on admission by malaria smear
- A previous history of intolerance or hypersensitivity to the study drugs or to drugs with similar chemical structures
- Malaria drug therapy administered in the past 30 days by history
- 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 2000)
- Unable and/or unlikely to comprehend and/or follow the protocol
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00639873
Start Date
June 1 2008
End Date
November 1 2009
Last Update
August 23 2013
Active Locations (1)
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1
Bandarban Sadar Hospital
Bandarban Sadar, Bandarban, Bangladesh