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NCT00643227 Clinical Trial

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643227
Other study ID # A0661075
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated March 19, 2008
Start date January 2003
Est. completion date March 2004

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 504
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• clarithromycin extended release (ER)
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
• azithromycin SR
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Tandil Buenos Aires
Argentina Pfizer Investigational Site Unknown Córdoba
Canada Pfizer Investigational Site Chicoutimi Quebec
Canada Pfizer Investigational Site Coquitlam British Columbia
Canada Pfizer Investigational Site Drummondville Quebec
Canada Pfizer Investigational Site Edmonton Alberta
Canada Pfizer Investigational Site Granby Quebec
Canada Pfizer Investigational Site Longueuil Quebec
Canada Pfizer Investigational Site Pointe Claire Quebec
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site St Jerome Quebec
Canada Pfizer Investigational Site St-John's Newfoundland and Labrador
Canada Pfizer Investigational Site Ste-Foy Quebec
Canada Pfizer Investigational Site Toronto Ontario
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tartu
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Coimbatore Tamil Nadu
India Pfizer Investigational Site Elamakkara, Cochin Kerala
India Pfizer Investigational Site Hyderabad Andhra Pradesh
India Pfizer Investigational Site Ludhiana Punjab
India Pfizer Investigational Site Pune Maharashtra
Lithuania Pfizer Investigational Site Kaunas
Lithuania Pfizer Investigational Site Vilnius
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Butte Montana
United States Pfizer Investigational Site Casper Wyoming
United States Pfizer Investigational Site Chalmette Louisiana
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Clemmons North Carolina
United States Pfizer Investigational Site Haleyville Alabama
United States Pfizer Investigational Site Holmdel New Jersey
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Meridian Idaho
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Milan Tennessee
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Montgomery Alabama
United States Pfizer Investigational Site Nampa Idaho
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Salisbury North Carolina
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Summerville South Carolina
United States Pfizer Investigational Site Tallassee Alabama
United States Pfizer Investigational Site Taylorsville Utah
United States Pfizer Investigational Site Tempe Arizona
United States Pfizer Investigational Site West Jordan Utah
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Estonia,  India,  Lithuania,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 14-21) No
Secondary bacteriologic response (eradication rate) in the Bacteriological Per Protocol population TOC visit No
Secondary investigator assessment of clinical response in the Clinical Per Protocol population TOC visit No
Secondary sponsor assessment of clinical response by baseline pathogen End of Treatment (EOT) visit (Day 8-11) and TOC visit No
Secondary sponsor assessment of clinical response in the non-primary population EOT visit and TOC visit No
Secondary sponsor assessment of clinical responses in the Clinical Per Protocol population EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) No
Secondary susceptibilities of baseline pathogens Study endpoint No
Secondary adverse events Continuous Yes
Secondary vital signs Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit Yes
Secondary physical examination Baseline Yes
Secondary clinical laboratory assessments (blood chemistry and hematology) Baseline and TOC visit Yes
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