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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| 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 | |
| Dispur Guwahati, Assam, India, 781006 | |
| Pfizer Investigational Site | |
| Bambolim, Gao, India, 403002 | |
| Pfizer Investigational Site | |
| Nagpur, Maharashtra, India, 440 018 | |
| Pfizer Investigational Site | |
| Parel Mumbai, Maharashtra, India, 400012 | |
| Pfizer Investigational Site | |
| Rourkela, Orissa, India, 769005 | |
| Pfizer Investigational Site | |
| Vellore, Tamil Nadu, India, 632 004 | |
| Pfizer Investigational Site | |
| Indore, India, 452001 | |
More Information
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00074841 History of Changes |
| Other Study ID Numbers: | A0661120 |
| Study First Received: | December 22, 2003 |
| Last Updated: | May 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
MALARIA INDIA CHLOROQUINE PLASMODIUM FALCIPARUM SULFADOXINE-PYRIMETHAMINE |
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Pyrimethamine Sulfadoxine Sulfadoxine-pyrimethamine Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents Folic Acid Antagonists |