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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of 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: clarithromycin extended release (ER) (Drug); azithromycin SR (Drug)

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 confirm that a single, 2. 0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1. 0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.

Clinical Details

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release 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 (clinical cure rate) in the Clinical Per Protocol population

Secondary outcome:

bacteriologic response (eradication rate) in the Bacteriological Per Protocol population

investigator assessment of clinical response in the Clinical Per Protocol population

sponsor assessment of clinical response by baseline pathogen

sponsor assessment of clinical response in the non-primary population

sponsor assessment of clinical responses in the Clinical Per Protocol population

susceptibilities of baseline pathogens

adverse events

vital signs

physical examination

clinical laboratory assessments (blood chemistry and hematology)

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II). Exclusion Criteria: Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.

Locations and Contacts

Pfizer Investigational Site, Buenos Aires C1120AAF, Argentina

Pfizer Investigational Site, Buenos Aires 1427, Argentina

Pfizer Investigational Site, Buenos Aires C1272AAA, Argentina

Pfizer Investigational Site, Buenos Aires C1282AFQ, Argentina

Pfizer Investigational Site, Tallinn 10617, Estonia

Pfizer Investigational Site, Tallinn 13419, Estonia

Pfizer Investigational Site, Tallinn 13619, Estonia

Pfizer Investigational Site, Tartu 51014, Estonia

Pfizer Investigational Site, Kaunas LT-3000, Lithuania

Pfizer Investigational Site, Vilnius LT-2010, 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, Birmingham, Alabama 35215, United States

Pfizer Investigational Site, Birmingham, Alabama 35242, United States

Pfizer Investigational Site, Haleyville, Alabama 35565, United States

Pfizer Investigational Site, Montgomery, Alabama 36106, United States

Pfizer Investigational Site, Montgomery, Alabama 36109, United States

Pfizer Investigational Site, Tallassee, Alabama 36078, United States

Pfizer Investigational Site, Edmonton, Alberta T5A 4L8, Canada

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 033, India

Pfizer Investigational Site, Mesa, Arizona 85201, United States

Pfizer Investigational Site, Phoenix, Arizona 85014, United States

Pfizer Investigational Site, Tempe, Arizona 85282, United States

Pfizer Investigational Site, Coquitlam, British Columbia V3K 3P4, Canada

Pfizer Investigational Site, Tandil, Buenos Aires B7000AXD, Argentina

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, San Diego, California 92128, United States

Pfizer Investigational Site, Unknown, Córdoba 5000, Argentina

Pfizer Investigational Site, Orlando, Florida 32806, United States

Pfizer Investigational Site, Boise, Idaho 83703, United States

Pfizer Investigational Site, Boise, Idaho 83704, United States

Pfizer Investigational Site, Boise, Idaho 83706, United States

Pfizer Investigational Site, Boise, Idaho 83709, United States

Pfizer Investigational Site, Boise, Idaho 83713, United States

Pfizer Investigational Site, Meridian, Idaho 83642, United States

Pfizer Investigational Site, Nampa, Idaho 83651, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Elamakkara, Cochin, Kerala 682 026, India

Pfizer Investigational Site, Chalmette, Louisiana 70043, United States

Pfizer Investigational Site, New Orleans, Louisiana 70112, United States

Pfizer Investigational Site, New Orleans, Louisiana 70128, United States

Pfizer Investigational Site, Pune, Maharashtra 411 053, India

Pfizer Investigational Site, Butte, Montana 59701, United States

Pfizer Investigational Site, Holmdel, New Jersey 07733, United States

Pfizer Investigational Site, St-John's, Newfoundland and Labrador A1E 2E2, Canada

Pfizer Investigational Site, Clemmons, North Carolina 27012, United States

Pfizer Investigational Site, Salisbury, North Carolina 28144, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

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

Pfizer Investigational Site, Ludhiana, Punjab 141 001, India

Pfizer Investigational Site, Chicoutimi, Quebec G7H 5H6, Canada

Pfizer Investigational Site, Drummondville, Quebec J2B 1H8, Canada

Pfizer Investigational Site, Granby, Quebec J2G 8Z9, Canada

Pfizer Investigational Site, Longueuil, Quebec J4N 1E1, Canada

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

Pfizer Investigational Site, St Jerome, Quebec J7Z 5T3, Canada

Pfizer Investigational Site, Ste-Foy, Quebec G1V 4G5, Canada

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 3H3, Canada

Pfizer Investigational Site, Charleston, South Carolina 29406, United States

Pfizer Investigational Site, Summerville, South Carolina 29485, United States

Pfizer Investigational Site, Coimbatore, Tamil Nadu 641 022, India

Pfizer Investigational Site, Milan, Tennessee 38358, 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, Salt Lake City, Utah 84102, United States

Pfizer Investigational Site, Taylorsville, Utah 84118, United States

Pfizer Investigational Site, West Jordan, Utah 84088, United States

Pfizer Investigational Site, Casper, Wyoming 82601, United States

Additional Information

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

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

Page last updated: August 23, 2015

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