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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 504
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
timeFrame: Test of Cure (TOC) visit (Day 14-21)
Secondary outcomes:
measure: bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
timeFrame: TOC visit
measure: investigator assessment of clinical response in the Clinical Per Protocol population
timeFrame: TOC visit
measure: sponsor assessment of clinical response by baseline pathogen
timeFrame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
measure: sponsor assessment of clinical response in the non-primary population
timeFrame: EOT visit and TOC visit
measure: sponsor assessment of clinical responses in the Clinical Per Protocol population
timeFrame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
measure: susceptibilities of baseline pathogens
timeFrame: Study endpoint
measure: adverse events
timeFrame: Continuous
measure: vital signs
timeFrame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
measure: physical examination
timeFrame: Baseline
measure: clinical laboratory assessments (blood chemistry and hematology)
timeFrame: Baseline and TOC visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Haleyville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tallassee
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Nampa
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chalmette
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Holmdel
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Clemmons
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Milan
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Taylorsville
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Casper
country: United States
facility: Pfizer Investigational Site
state: Wyoming
city: Tandil
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: St-John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Drummondville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Granby
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Longueuil
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St Jerome
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Elamakkara, Cochin
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: