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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia

Intervention: azithromycin sustained release (Drug); placebo (Other); levofloxacin (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The study was performed to see if a single, 2. 0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population

Secondary outcome:

laboratory abnormalities

sponsor assessment of clinical response (cure or failure) in the remaining study populations

sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population

investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population

bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population

summary of baseline susceptibilities

adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included. Exclusion Criteria: Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e. g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.

Locations and Contacts

Pfizer Investigational Site, Alytus LT-4580, Lithuania

Pfizer Investigational Site, Kaunas LT-3021, Lithuania

Pfizer Investigational Site, Klaipeda LT-5800, Lithuania

Pfizer Investigational Site, Moscow 105077, Russian Federation

Pfizer Investigational Site, Moscow 105229, Russian Federation

Pfizer Investigational Site, Moscow 107066, Russian Federation

Pfizer Investigational Site, Moscow 119048, Russian Federation

Pfizer Investigational Site, Moscow, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, Mesa, Arizona 85206, United States

Pfizer Investigational Site, Phoenix, Arizona 85014, United States

Pfizer Investigational Site, Langley, British Columbia V3A 4H9, Canada

Pfizer Investigational Site, San Luis Obispo, California 93401, United States

Pfizer Investigational Site, San Mateo, California 94403, United States

Pfizer Investigational Site, Highlands Ranch, Colorado 80130, United States

Pfizer Investigational Site, Newark, Delaware 19702, United States

Pfizer Investigational Site, Kissimmee, Florida 34741, United States

Pfizer Investigational Site, Merrit Island, Florida 32953, United States

Pfizer Investigational Site, Evansville, Indiana 47714, United States

Pfizer Investigational Site, Evansville, Indiana 47712, United States

Pfizer Investigational Site, Indianapolis, Indiana 46254, United States

Pfizer Investigational Site, Dubuque, Iowa 52001, United States

Pfizer Investigational Site, Pratt, Kansas 67124, United States

Pfizer Investigational Site, Bangalore, Karnataka 560052, India

Pfizer Investigational Site, Bangalore, Karnataka 560054, India

Pfizer Investigational Site, Madisonville, Kentucky 42431, United States

Pfizer Investigational Site, San Isidro, Lima, Peru

Pfizer Investigational Site, San Miguel, Lima, Peru

Pfizer Investigational Site, Indore, Madhya Pradesh, India

Pfizer Investigational Site, Mumbai, Maharashtra 400 012, India

Pfizer Investigational Site, Nagpur, Maharashtra, India

Pfizer Investigational Site, Cumberland, Maryland 21502, United States

Pfizer Investigational Site, Kalamazoo, Michigan 49009, United States

Pfizer Investigational Site, Olive Branch, Mississippi 38654, United States

Pfizer Investigational Site, Elkhorn, Nebraska 68022, United States

Pfizer Investigational Site, Omaha, Nebraska 68144, United States

Pfizer Investigational Site, Rio Rancho, New Mexico 87124, United States

Pfizer Investigational Site, Charlotte, North Carolina 28209, United States

Pfizer Investigational Site, Charlotte, North Carolina 28210, United States

Pfizer Investigational Site, Charlotte, North Carolina 28262, United States

Pfizer Investigational Site, Hickory, North Carolina 28601, United States

Pfizer Investigational Site, Monterrey, Nuevo León 64460, Mexico

Pfizer Investigational Site, Yukon, Oklahoma 73099, United States

Pfizer Investigational Site, Hawkesbury, Ontario K6A 1A1, Canada

Pfizer Investigational Site, Kitchener, Ontario N2C 2N9, Canada

Pfizer Investigational Site, Toronto, Ontario M9W 4L6, Canada

Pfizer Investigational Site, Downingtown, Pennsylvania 19335, United States

Pfizer Investigational Site, King of Prussia, Pennsylvania 19406, United States

Pfizer Investigational Site, Morrisville, Pennsylvania 19067, United States

Pfizer Investigational Site, Montreal, Quebec H3H 1V4, Canada

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Ste-foy, Quebec G1V 4P9, Canada

Pfizer Investigational Site, Victoriaville, Quebec G6P 6N2, Canada

Pfizer Investigational Site, Providencia, Santiago, Chile

Pfizer Investigational Site, North Battleford, Saskatchewan S9A 0V6, Canada

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 7H9, Canada

Pfizer Investigational Site, Greer, South Carolina 29651, United States

Pfizer Investigational Site, Chennai, Tamilnadu 600116, India

Pfizer Investigational Site, Vellore, Tamilnadu 632002, India

Pfizer Investigational Site, Dyersburg, Tennessee 38024, United States

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States

Pfizer Investigational Site, Walla Walla, Washington 99362, United States

Pfizer Investigational Site, Menomonee Falls, Wisconsin 53051, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2003
Last updated: March 19, 2008

Page last updated: August 23, 2015

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