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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00299208 |
The goal of this study is to develop a safe, well tolerated, and highly efficacious azithromycin combination treatment for uncomplicated falciparum malaria. Azithromycin is a drug that has shown potential for malaria treatment. It will be combined with other malaria drugs currently approved for treatment in Thailand. About 120 people, ages 20-65, will be enrolled in Thailand. Participants will have severe cases of malaria and they will be hospitalized 28 days for treatment.
Condition | Intervention | Phase |
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Plasmodium Falciparum Malaria |
Drug: Artesunate Drug: Azithromycin Drug: Quinine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II, Open Label, Randomized Study of Azithromycin Combination Therapy for the Treatment of Acute, Uncomplicated Falciparum Malaria |
Estimated Enrollment: | 120 |
The study is aimed at identifying a well tolerated, practical and highly efficacious treatment regimen of azithromycin in combination with artesunate or quinine for uncomplicated falciparum malaria for future studies, to monitor for the tolerability and safety of these combination regimens and to compare tolerability, safety and efficacy of azithromycin when given in combination with artesunate as compared to quinine. This study is also aimed at comparing tolerability, safety and efficacy of the combination of artesunate and azithromycin when given as a single daily dose (200mg As+1000mg Az) for 3 days as compared to 2 doses of 100mg As+750mg Az per day for 3 days and to compare the tolerability, safety and efficacy of the combination of quinine and azithromycin when given as 3 daily doses of quinine (10mg/kg) + Az 500mg vs. 2 daily doses of quinine (10mg/kg) + Az 750mg when given for 3 days.
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory evidence or history of significant cardiovascular, liver or renal functional abnormality, which in the opinion of the investigator would place them at increased risk. Specifically, the following will serve as exclusionary laboratory values:
Study ID Numbers: | 03-149, A0661129 |
Study First Received: | March 3, 2006 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00299208 History of Changes |
Health Authority: | Unspecified |
Malaria |
Artesunate Anti-Bacterial Agents Antimalarials Protozoan Infections Quinine |
Azithromycin Parasitic Diseases Malaria Malaria, Falciparum |
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 |