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NCT00643734 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643734
Other study ID # A0661103
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated March 19, 2008
Start date April 2003
Est. completion date April 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 468
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

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:
• azithromycin sustained release
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
Other:
• placebo
placebo
Drug:
• levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days
Other:
• placebo
placebo

Locations
Country Name City State
Canada Pfizer Investigational Site Hawkesbury Ontario
Canada Pfizer Investigational Site Kitchener Ontario
Canada Pfizer Investigational Site Langley British Columbia
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site North Battleford Saskatchewan
Canada Pfizer Investigational Site Pointe-Claire Quebec
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Ste-foy Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Victoriaville Quebec
Chile Pfizer Investigational Site Providencia Santiago
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Chennai Tamilnadu
India Pfizer Investigational Site Indore Madhya Pradesh
India Pfizer Investigational Site Mumbai Maharashtra
India Pfizer Investigational Site Nagpur Maharashtra
India Pfizer Investigational Site Vellore Tamilnadu
Lithuania Pfizer Investigational Site Alytus
Lithuania Pfizer Investigational Site Kaunas
Lithuania Pfizer Investigational Site Klaipeda
Mexico Pfizer Investigational Site Monterrey Nuevo León
Peru Pfizer Investigational Site San Isidro Lima
Peru Pfizer Investigational Site San Miguel Lima
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 Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cumberland Maryland
United States Pfizer Investigational Site Downingtown Pennsylvania
United States Pfizer Investigational Site Dubuque Iowa
United States Pfizer Investigational Site Dyersburg Tennessee
United States Pfizer Investigational Site Elkhorn Nebraska
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Evansville Indiana
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Hickory North Carolina
United States Pfizer Investigational Site Highlands Ranch Colorado
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site King of Prussia Pennsylvania
United States Pfizer Investigational Site Kissimmee Florida
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Menomonee Falls Wisconsin
United States Pfizer Investigational Site Merrit Island Florida
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Morrisville Pennsylvania
United States Pfizer Investigational Site Newark Delaware
United States Pfizer Investigational Site Olive Branch Mississippi
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Pratt Kansas
United States Pfizer Investigational Site Rio Rancho New Mexico
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Luis Obispo California
United States Pfizer Investigational Site San Mateo California
United States Pfizer Investigational Site Walla Walla Washington
United States Pfizer Investigational Site Yukon Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Chile,  India,  Lithuania,  Mexico,  Peru,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population Test of Cure (TOC) visit (Days 14-21) No
Secondary laboratory abnormalities Baseline and TOC visit Yes
Secondary sponsor assessment of clinical response (cure or failure) in the remaining study populations EOT visit and TOC visit No
Secondary sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population EOT visit and TOC visit No
Secondary investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population TOC visit No
Secondary sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population End of Treatment (EOT) visit (Days 8-11) No
Secondary bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit No
Secondary sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population Long-Term Follow-Up (LTFU) visit (Days 28-35) No
Secondary summary of baseline susceptibilities Study endpoint No
Secondary adverse events Continuous Yes
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