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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00367653 |
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
Condition | Intervention | Phase |
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Malaria |
Drug: Azithromycin plus Chloroquine Drug: Mefloquine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa |
Enrollment: | 397 |
Study Start Date: | November 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Azithromycin plus Chloroquine
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
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2: Experimental |
Drug: Mefloquine
Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Burkina Faso | |
Pfizer Investigational Site | |
Nouna, Burkina Faso | |
Burkina Faso, West Africa | |
Pfizer Investigational Site | |
Ouagadougou, West Africa, Burkina Faso, 01 | |
Ghana, West Africa | |
Pfizer Investigational Site | |
Navrongo, West Africa, Ghana | |
Kenya | |
Pfizer Investigational Site | |
kisumu, Kenya, 40100 | |
Mali | |
Pfizer Investigational Site | |
Bamako, Mali | |
Mali, West Africa | |
Pfizer Investigational Site | |
Bamako, West Africa, Mali | |
Senegal, West Africa | |
Pfizer Investigational Site | |
Senegal, West Africa, Senegal | |
Zambia | |
Pfizer Investigational Site | |
Ndola, Zambia |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661155 |
Study First Received: | August 21, 2006 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00367653 |
Health Authority: | United States: Food and Drug Administration |
Protozoan Infections Chloroquine diphosphate Azithromycin Chloroquine |
Parasitic Diseases Malaria Mefloquine Malaria, Falciparum |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Filaricides Coccidiosis Physiological Effects of Drugs Anthelmintics Pharmacologic Actions Anti-Bacterial Agents Antimalarials Antiparasitic Agents |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Amebicides Analgesics Antirheumatic Agents Central Nervous System Agents Antinematodal Agents |