Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
126 participants
INTERVENTIONAL
2008-06-30
2009-11-30
Brief Summary
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Detailed Description
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The artesunate will be administered orally (a single dose of 2 or 4 mg/kg/day) over a total duration of 7 days by directly observed therapy.
Patients will be admitted to the hospital for the duration of study drug administration or until all signs and symptoms of malaria have disappeared, whichever comes later. Thereafter they will be followed as outpatients until Day 42 with scheduled follow-up visits on Day 14, 28, 35, and 42.
In vitro drug sensitivity assays will be performed from samples on inclusion and in case of recrudescence. Drug levels will be measured on the first and last day of therapy.
Primary clinical outcome is cure (Adequate Clinical and Parasitological Response - ACPR) on Day 28 and 42. Secondary outcome measures are time until parasite, fever, and gametocyte clearance (PCT, FCT, and GCT). Parasite genotyping will be used to distinguish recrudescences from reinfections by PCR for patients in whom recrudescences cannot be fully excluded. Subjects will be monitored for clinical adverse events throughout the study duration.
Blood will be drawn on the day of admission (before initiating therapy) for in vitro drug sensitivity testing and for PCR (markers of drug resistance and to distinguish recrudescence from reinfection by genotyping). Malaria smears will be prepared twice daily until parasite clearance and on Days 7, 14, 21, 28, 35, and 42 or whenever symptoms consistent with malaria appear. Plasma samples for determining drug levels will be obtained on the first and last day of therapy. Study participation for each individual will be 42 days.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AS 2mg/kg
Artesunate monotherapy 2mg/kg/day for 7 days
Artesunate
2 or 4 mg/kg/day for 7 days
AS 4mg/kg
Artesunate monotherapy 4mg/kg/day for 7 days
Artesunate
2 or 4 mg/kg/day for 7 days
QD Control
Quinine-doxycycline for 7 days
quinine-doxycycline
quinine-doxycycline for 7 days
Interventions
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Artesunate
2 or 4 mg/kg/day for 7 days
quinine-doxycycline
quinine-doxycycline for 7 days
Eligibility Criteria
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Inclusion Criteria
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
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
8 Years
65 Years
ALL
No
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
World Health Organization
OTHER
Medical University of Vienna
OTHER
Responsible Party
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Harald Noedl
Assoc. Prof. Dr.
Principal Investigators
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Harald Noedl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Bandarban Sadar Hospital
Bandarban Sadar, Bandarban, Bangladesh
Countries
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References
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Starzengruber P, Swoboda P, Fuehrer HP, Khan WA, Hofecker V, Siedl A, Fally M, Graf O, Teja-Isavadharm P, Haque R, Ringwald P, Noedl H. Current status of artemisinin-resistant falciparum malaria in South Asia: a randomized controlled artesunate monotherapy trial in Bangladesh. PLoS One. 2012;7(12):e52236. doi: 10.1371/journal.pone.0052236. Epub 2012 Dec 18.
Related Links
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MARIB - Malaria Research Initiative Bandarban
Medical University of Vienna
ICDDR,B
Other Identifiers
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MUW # 83/2008
Identifier Type: -
Identifier Source: org_study_id