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Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India
This study has been completed.
First Received: December 22, 2003   Last Updated: January 30, 2006   History of Changes
Sponsored by: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Estimated Enrollment: 219
Study Start Date: September 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074841

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
Sponsors and Collaborators
Pfizer
  More Information

Additional Information:
No publications provided

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

Keywords provided by Pfizer:
MALARIA
INDIA
CHLOROQUINE
PLASMODIUM FALCIPARUM
SULFADOXINE-PYRIMETHAMINE

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 04, 2009