Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India
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ClinicalTrials.gov Identifier: NCT00074841 |
Recruitment Status :
Completed
First Posted : December 24, 2003
Last Update Posted : May 10, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
PLASMODIUM FALCIPARUM MALARIA | Drug: Azithromycin/Chloroquine Drug: Sulfadoxine-Pyrimethamine/Chloroquine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 230 participants |
Allocation: | Randomized |
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 |
Study Start Date : | September 2003 |
Actual Study Completion Date : | January 2005 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/uL; b.) Fever or history of fever ( >=38.5C/101.2F rectal or tympanic; >=37.5C/99.5F axillary or >=38C/100.4F oral) within the prior 24 hours
- Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection)
- Positive rapid diagnostic test (Binax NOW ICT) positive for P. falciparum
- Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study
EXCLUSION CRITERIA:
- Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness (e.g. obtundation, unarousable coma), seizures or abnormal neurologic exam suggestive of severe or complicated malaria; b.) Hemoglobinuria; c.) Jaundice; d.) Respiratory distress (respiratory rate >=30/min); e.) Persistent vomiting; f.) Hematuria, as reported by the patient
- Pregnant or breast-feeding women
- History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine
- Known or suspected folate deficiency
- Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia)
- Known G-6PD deficiency
- History of epilepsy or psoriasis
- History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study
- Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) Serum creatinine >2.0 x ULN; b.) ALT and/or AST >3 x ULN
- Inability to swallow oral medication in tablet form
- Treatment with other investigational drugs within 30 days prior to enrollment into the study
- Alcohol and/or any other drug abuse
- Requirement to use medication during the study that might interfere with the evaluation of the study drug
- Specific systemic diseases or other medical conditions that would interfere with the evaluation of the therapeutic response or safety of the study drug
- Inability to comprehend and/or unwillingness to follow the study protocol
- Prior participation in this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074841
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 |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
ClinicalTrials.gov Identifier: | NCT00074841 |
Other Study ID Numbers: |
A0661120 |
First Posted: | December 24, 2003 Key Record Dates |
Last Update Posted: | May 10, 2011 |
Last Verified: | May 2011 |
MALARIA INDIA CHLOROQUINE PLASMODIUM FALCIPARUM SULFADOXINE-PYRIMETHAMINE |
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Infections Vector Borne Diseases Azithromycin Chloroquine Chloroquine diphosphate Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Anti-Bacterial Agents Anti-Infective Agents Amebicides |
Antiprotozoal Agents Antiparasitic Agents 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 Folic Acid Antagonists |