- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00643227
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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- Pfizer Investigational Site
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Buenos Aires, Argentina, 1427
- Pfizer Investigational Site
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Buenos Aires, Argentina, C1120AAF
- Pfizer Investigational Site
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Buenos Aires, Argentina, C1272AAA
- Pfizer Investigational Site
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Buenos Aires, Argentina, C1282AFQ
- Pfizer Investigational Site
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Buenos Aires
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Tandil, Buenos Aires, Argentina, B7000AXD
- Pfizer Investigational Site
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
- Pfizer Investigational Site
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British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
- Pfizer Investigational Site
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Newfoundland and Labrador
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St-John's, Newfoundland and Labrador, Canada, A1E 2E2
- Pfizer Investigational Site
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Ontario
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Toronto, Ontario, Canada, M9W 4L6
- Pfizer Investigational Site
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Quebec
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Chicoutimi, Quebec, Canada, G7H 5H6
- Pfizer Investigational Site
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Drummondville, Quebec, Canada, J2B 1H8
- Pfizer Investigational Site
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Granby, Quebec, Canada, J2G 8Z9
- Pfizer Investigational Site
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Longueuil, Quebec, Canada, J4N 1E1
- Pfizer Investigational Site
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Pointe Claire, Quebec, Canada, H9R 4S3
- Pfizer Investigational Site
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St Jerome, Quebec, Canada, J7Z 5T3
- Pfizer Investigational Site
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Ste-Foy, Quebec, Canada, G1V 4G5
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 3H3
- Pfizer Investigational Site
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Tallinn, Estonia, 13419
- Pfizer Investigational Site
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Tallinn, Estonia, 10617
- Pfizer Investigational Site
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Tallinn, Estonia, 13619
- Pfizer Investigational Site
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Tartu, Estonia, 51014
- Pfizer Investigational Site
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500 033
- Pfizer Investigational Site
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Karnataka
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Bangalore, Karnataka, India, 560 034
- Pfizer Investigational Site
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Kerala
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Elamakkara, Cochin, Kerala, India, 682 026
- Pfizer Investigational Site
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Maharashtra
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Pune, Maharashtra, India, 411 053
- Pfizer Investigational Site
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Punjab
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Ludhiana, Punjab, India, 141 001
- Pfizer Investigational Site
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641 022
- Pfizer Investigational Site
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Kaunas, Lithuania, LT-3000
- Pfizer Investigational Site
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Vilnius, Lithuania, LT-2010
- Pfizer Investigational Site
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Moscow, Russian Federation, 105077
- Pfizer Investigational Site
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Moscow, Russian Federation, 105229
- Pfizer Investigational Site
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Moscow, Russian Federation
- Pfizer Investigational Site
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Moscow, Russian Federation, 107066
- Pfizer Investigational Site
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Moscow, Russian Federation, 119048
- Pfizer Investigational Site
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Smolensk, Russian Federation, 214019
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35215
- Pfizer Investigational Site
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Birmingham, Alabama, United States, 35242
- Pfizer Investigational Site
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Haleyville, Alabama, United States, 35565
- Pfizer Investigational Site
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Montgomery, Alabama, United States, 36106
- Pfizer Investigational Site
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Montgomery, Alabama, United States, 36109
- Pfizer Investigational Site
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Tallassee, Alabama, United States, 36078
- Pfizer Investigational Site
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Arizona
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Mesa, Arizona, United States, 85201
- Pfizer Investigational Site
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Phoenix, Arizona, United States, 85014
- Pfizer Investigational Site
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Tempe, Arizona, United States, 85282
- Pfizer Investigational Site
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California
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La Jolla, California, United States, 92037
- Pfizer Investigational Site
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San Diego, California, United States, 92128
- Pfizer Investigational Site
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Florida
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Orlando, Florida, United States, 32806
- Pfizer Investigational Site
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Idaho
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Boise, Idaho, United States, 83704
- Pfizer Investigational Site
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Boise, Idaho, United States, 83703
- Pfizer Investigational Site
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Boise, Idaho, United States, 83706
- Pfizer Investigational Site
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Boise, Idaho, United States, 83709
- Pfizer Investigational Site
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Boise, Idaho, United States, 83713
- Pfizer Investigational Site
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Meridian, Idaho, United States, 83642
- Pfizer Investigational Site
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Nampa, Idaho, United States, 83651
- Pfizer Investigational Site
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Louisiana
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Chalmette, Louisiana, United States, 70043
- Pfizer Investigational Site
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New Orleans, Louisiana, United States, 70112
- Pfizer Investigational Site
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New Orleans, Louisiana, United States, 70128
- Pfizer Investigational Site
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Montana
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Butte, Montana, United States, 59701
- Pfizer Investigational Site
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New Jersey
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Holmdel, New Jersey, United States, 07733
- Pfizer Investigational Site
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North Carolina
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Clemmons, North Carolina, United States, 27012
- Pfizer Investigational Site
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Salisbury, North Carolina, United States, 28144
- Pfizer Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29406
- Pfizer Investigational Site
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Summerville, South Carolina, United States, 29485
- Pfizer Investigational Site
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Tennessee
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Milan, Tennessee, United States, 38358
- Pfizer Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84102
- Pfizer Investigational Site
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Salt Lake City, Utah, United States, 84109
- Pfizer Investigational Site
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Salt Lake City, Utah, United States, 84121
- Pfizer Investigational Site
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Taylorsville, Utah, United States, 84118
- Pfizer Investigational Site
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West Jordan, Utah, United States, 84088
- Pfizer Investigational Site
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Wyoming
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Casper, Wyoming, United States, 82601
- Pfizer Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
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Experimental: 2
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Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Time Frame: Test of Cure (TOC) visit (Day 14-21)
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Test of Cure (TOC) visit (Day 14-21)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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adverse events
Time Frame: Continuous
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Continuous
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bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Time Frame: TOC visit
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TOC visit
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investigator assessment of clinical response in the Clinical Per Protocol population
Time Frame: TOC visit
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TOC visit
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sponsor assessment of clinical response by baseline pathogen
Time Frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
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End of Treatment (EOT) visit (Day 8-11) and TOC visit
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sponsor assessment of clinical response in the non-primary population
Time Frame: EOT visit and TOC visit
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EOT visit and TOC visit
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sponsor assessment of clinical responses in the Clinical Per Protocol population
Time Frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
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EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
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susceptibilities of baseline pathogens
Time Frame: Study endpoint
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Study endpoint
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vital signs
Time Frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
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Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
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physical examination
Time Frame: Baseline
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Baseline
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clinical laboratory assessments (blood chemistry and hematology)
Time Frame: Baseline and TOC visit
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Baseline and TOC visit
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
- Azithromycin
Other Study ID Numbers
- A0661075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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