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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00082576 |
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
Condition | Intervention | Phase |
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Malaria, Falciparum |
Drug: Azithromycin/Chloroquine Drug: Mefloquine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III, Randomized, Double-Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ghana | |
Pfizer Investigational Site | |
Navrongo, Ghana | |
Kenya, Nairobi | |
Pfizer Investigational Site | |
Unknown, Nairobi, Kenya | |
Mali | |
Pfizer Investigational Site | |
Bamako, Mali | |
Uganda | |
Pfizer Investigational Site | |
Jinja, Uganda | |
Pfizer Investigational Site | |
Kampala, Uganda | |
Zambia | |
Pfizer Investigational Site | |
Ndola, Zambia |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Study ID Numbers: | A0661134 |
Study First Received: | May 12, 2004 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00082576 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Protozoan Infections Anti-Infective Agents Chloroquine Anthelmintics Malaria Malaria, Falciparum Anti-Bacterial Agents Antimalarials |
Analgesics, Non-Narcotic Azithromycin Chloroquine diphosphate Parasitic Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Mefloquine Antirheumatic Agents |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Physiological Effects of Drugs Malaria Anti-Bacterial Agents Antimalarials Antiparasitic Agents Sensory System Agents Azithromycin Therapeutic Uses Parasitic Diseases Anti-Inflammatory Agents, Non-Steroidal Amebicides Mefloquine |
Analgesics Antinematodal Agents Protozoan Infections Coccidiosis Filaricides Chloroquine Anthelmintics Pharmacologic Actions Malaria, Falciparum Analgesics, Non-Narcotic Chloroquine diphosphate Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |