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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00074841 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Contacts and Locations| 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 | |
More Information
| 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 |
|
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 |