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Sponsors and Collaborators: |
Medical University of Vienna International Centre for Diarrhoeal Disease Research, Bangladesh World Health Organization |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00639873 |
A randomized, controlled clinical trial conducted in Southeastern Bangladesh using artesunate monotherapy to determine the baseline sensitivity of P. falciparum to artemisinins.
Condition | Intervention |
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P. Falciparum Malaria |
Drug: Artesunate Drug: quinine-doxycycline |
Study Type: | Interventional |
Official Title: | Artemisinin Resistance in Bangladesh |
Arms | Assigned Interventions |
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1: Active Comparator
Artesunate monotherapy 2mg/kg/day for 7 days
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Drug: Artesunate
2 or 4 mg/kg/day for 7 days
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2: Experimental
Artesunate monotherapy 4mg/kg/day for 7 days
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Drug: Artesunate
2 or 4 mg/kg/day for 7 days
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3: Active Comparator
Quinine-doxycycline for 7 days
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Drug: quinine-doxycycline
quinine-doxycycline for 7 days
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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 ratio of 2:2:1. 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). Study participants will be otherwise healthy malaria patients aged 8 to 65 years with uncomplicated falciparum malaria recruited at the Bandarban Sadar Hospital, Bangladesh. 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.
Ages Eligible for Study: | 8 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Harald Noedl, MD, PhD | +43-1-4277-64882 | harald.noedl@meduniwien.ac.at |
Bangladesh, Bandarban | |
Bandarban Sadar Hospital | Recruiting |
Bandarban Sadar, Bandarban, Bangladesh | |
Principal Investigator: Harald Noedl, MD, PhD | |
Principal Investigator: Wasif A Khan, MD, MPh |
Study ID Numbers: | MUW # 83/2008 |
Study First Received: | March 14, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00639873 History of Changes |
Health Authority: | Switzerland: Ethikkommission |
Uncomplicated P. falciparum malaria |
Artesunate Protozoan Infections Anti-Infective Agents Quinine Artemisinine Malaria Malaria, Falciparum Anti-Bacterial Agents Antimalarials |
Artemisinins Analgesics, Non-Narcotic Muscle Relaxants, Central Red Cinchona Parasitic Diseases Analgesics Peripheral Nervous System Agents Doxycycline |
Anti-Infective Agents Antiprotozoal Agents Quinine Physiological Effects of Drugs Malaria Neuromuscular Agents Anti-Bacterial Agents Antimalarials Antiparasitic Agents Artemisinins Sensory System Agents Therapeutic Uses Muscle Relaxants, Central |
Parasitic Diseases Analgesics Amebicides Artesunate Protozoan Infections Coccidiosis Pharmacologic Actions Malaria, Falciparum Analgesics, Non-Narcotic Peripheral Nervous System Agents Central Nervous System Agents Doxycycline |