Clinical trial NCT00643734: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: Test of Cure (TOC) visit (Days 14-21)
Secondary outcomes:
measure: laboratory abnormalities
timeFrame: Baseline and TOC visit
measure: sponsor assessment of clinical response (cure or failure) in the remaining study populations
timeFrame: EOT visit and TOC visit
measure: sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
timeFrame: EOT visit and TOC visit
measure: investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: TOC visit
measure: sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: End of Treatment (EOT) visit (Days 8-11)
measure: bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
timeFrame: TOC visit
measure: sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
timeFrame: Long-Term Follow-Up (LTFU) visit (Days 28-35)
measure: summary of baseline susceptibilities
timeFrame: Study endpoint
measure: adverse events
timeFrame: Continuous
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Luis Obispo
country: United States
facility: Pfizer Investigational Site
state: California
city: San Mateo
country: United States
facility: Pfizer Investigational Site
state: California
city: Highlands Ranch
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Merrit Island
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Pratt
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Cumberland
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Elkhorn
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Rio Rancho
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Yukon
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Downingtown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: King of Prussia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Morrisville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dyersburg
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
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: Walla Walla
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Langley
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Victoriaville
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: North Battleford
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Vellore
country: India
facility: Pfizer Investigational Site
state: Tamilnadu
city: Alytus
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo León
city: San Isidro
country: Peru
facility: Pfizer Investigational Site
state: Lima
city: San Miguel
country: Peru
facility: Pfizer Investigational Site
state: Lima
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
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: