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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00639873 |
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Date of registration:
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14/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Artemisinin Resistance in Bangladesh
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Scientific title:
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Artemisinin Resistance in Bangladesh |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00639873 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Harald Noedl, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Age: 8-65 years old
3. 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
4. Written informed consent obtained
5. Willing to stay under close medical supervision for the study duration of 42 days
6. Otherwise healthy outpatients
Exclusion Criteria:
1. Pregnant women, nursing mothers, or women of childbearing potential who do not use an
acceptable method of contraception
2. Mixed malaria infection on admission by malaria smear
3. A previous history of intolerance or hypersensitivity to the study drugs or to drugs
with similar chemical structures
4. Malaria drug therapy administered in the past 30 days by history
5. 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.
6. Symptoms of severe vomiting (no food or inability to take food during the previous 8
hours).
7. Signs or symptoms of severe malaria (as defined by WHO 2000)
8. Unable and/or unlikely to comprehend and/or follow the protocol
Age minimum:
8 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: quinine-doxycycline
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Drug: Artesunate
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Primary Outcome(s)
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Cure
[Time Frame: 42 days]
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Secondary Outcome(s)
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Treatment response
[Time Frame: 42 Days]
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Secondary ID(s)
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MUW # 83/2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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