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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00074841 |
This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India.
Condition | Intervention | Phase |
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Plasmodium Falciparum Malaria |
Drug: Azithromycin/Chloroquine Drug: Sulfadoxine-Pyrimethamine/Chloroquine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control, Efficacy Study |
Official Title: | A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
India | |
Pfizer Investigational Site | |
Indore, India, 452001 | |
India, Assam | |
Pfizer Investigational Site | |
Dispur Guwahati, Assam, India, 781006 | |
India, Gao | |
Pfizer Investigational Site | |
Bambolim, Gao, India, 403002 | |
India, Maharashtra | |
Pfizer Investigational Site | |
Parel Mumbai, Maharashtra, India, 400012 | |
Pfizer Investigational Site | |
Nagpur, Maharashtra, India, 440 018 | |
India, Orissa | |
Pfizer Investigational Site | |
Rourkela, Orissa, India, 769005 | |
India, Tamil Nadu | |
Pfizer Investigational Site | |
Vellore, Tamil Nadu, India, 632 004 |
Study ID Numbers: | A0661120 |
Study First Received: | December 22, 2003 |
Last Updated: | January 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00074841 History of Changes |
Health Authority: | United States: Food and Drug Administration |
MALARIA INDIA CHLOROQUINE PLASMODIUM FALCIPARUM SULFADOXINE-PYRIMETHAMINE |
Pyrimethamine Anti-Inflammatory Agents Anti-Infective Agents Folate Malaria Vitamin B9 Antimalarials Anti-Bacterial Agents Azithromycin Parasitic Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Protozoan Infections |
Sulfadoxine-pyrimethamine Chloroquine Anthelmintics Anti-Infective Agents, Urinary Sulfadoxine Folic Acid Antagonists Folinic Acid Malaria, Falciparum Folic Acid Analgesics, Non-Narcotic Chloroquine diphosphate Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Pyrimethamine Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Malaria Renal Agents Anti-Bacterial Agents Antimalarials Antiparasitic Agents Sensory System Agents Azithromycin Therapeutic Uses Parasitic Diseases |
Anti-Inflammatory Agents, Non-Steroidal Amebicides Analgesics Antinematodal Agents Protozoan Infections Sulfadoxine-pyrimethamine Filaricides Coccidiosis Chloroquine Anti-Infective Agents, Urinary Enzyme Inhibitors Anthelmintics Folic Acid Antagonists Sulfadoxine Pharmacologic Actions |