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| Sponsor: | Medical University of Vienna |
|---|---|
| Collaborators: |
International Centre for Diarrhoeal Disease Research, Bangladesh Armed Forces Research Institute of Medical Sciences, Thailand |
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00356005 |
Purpose
The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.
| Condition | Intervention | Phase |
|---|---|---|
|
Uncomplicated Falciparum Malaria |
Drug: azithromycin plus artesunate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh: An Open Label Randomized Controlled Trial |
| Enrollment: | 228 |
| Study Start Date: | August 2006 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh.
Eligibility| Ages Eligible for Study: | 8 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Bangladesh | |
| Sadar Hospital | |
| Bandarban, Bangladesh | |
| Principal Investigator: | Rashidul Haque, MBBS,PhD | ICDDR, B |
| Principal Investigator: | Harald Noedl, MD, MCTM,PhD | Medical University of Vienna |
More Information
| Study ID Numbers: | ICDDRB #2006-024, MUW #218/2006 |
| Study First Received: | July 24, 2006 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00356005 History of Changes |
| Health Authority: | Bangladesh: Ethical Review Committee; Austria: Ethikkommission |
|
falciparum malaria therapy azithromycin |
artesunate Coartem Bangladesh |
|
Artesunate Protozoan Infections Anti-Infective Agents Antiprotozoal Agents Coccidiosis Malaria Pharmacologic Actions Malaria, Falciparum |
Anti-Bacterial Agents Antimalarials Antiparasitic Agents Azithromycin Therapeutic Uses Parasitic Diseases Amebicides |