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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

Primary Purpose

Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
azithromycin sustained release
placebo
levofloxacin
placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population

Secondary Outcome Measures

laboratory abnormalities
sponsor assessment of clinical response (cure or failure) in the remaining study populations
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
summary of baseline susceptibilities
adverse events

Full Information

First Posted
March 19, 2008
Last Updated
March 19, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00643734
Brief Title
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

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
azithromycin sustained release
Intervention Description
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Intervention Description
500 mg (two 250 mg capsules) by mouth once daily for 7 days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
Test of Cure (TOC) visit (Days 14-21)
Secondary Outcome Measure Information:
Title
laboratory abnormalities
Time Frame
Baseline and TOC visit
Title
sponsor assessment of clinical response (cure or failure) in the remaining study populations
Time Frame
EOT visit and TOC visit
Title
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time Frame
EOT visit and TOC visit
Title
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
TOC visit
Title
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
End of Treatment (EOT) visit (Days 8-11)
Title
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame
TOC visit
Title
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
Long-Term Follow-Up (LTFU) visit (Days 28-35)
Title
summary of baseline susceptibilities
Time Frame
Study endpoint
Title
adverse events
Time Frame
Continuous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Pfizer Investigational Site
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Pfizer Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94403
Country
United States
Facility Name
Pfizer Investigational Site
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
Facility Name
Pfizer Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19702
Country
United States
Facility Name
Pfizer Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Pfizer Investigational Site
City
Merrit Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Facility Name
Pfizer Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Pfizer Investigational Site
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
Pfizer Investigational Site
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Pfizer Investigational Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Pfizer Investigational Site
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pfizer Investigational Site
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Pfizer Investigational Site
City
Elkhorn
State/Province
Nebraska
ZIP/Postal Code
68022
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Pfizer Investigational Site
City
Rio Rancho
State/Province
New Mexico
ZIP/Postal Code
87124
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Pfizer Investigational Site
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Pfizer Investigational Site
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Pfizer Investigational Site
City
King of Prussia
State/Province
Pennsylvania
ZIP/Postal Code
19406
Country
United States
Facility Name
Pfizer Investigational Site
City
Morrisville
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Dyersburg
State/Province
Tennessee
ZIP/Postal Code
38024
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Pfizer Investigational Site
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Pfizer Investigational Site
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Pfizer Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4P9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6N2
Country
Canada
Facility Name
Pfizer Investigational Site
City
North Battleford
State/Province
Saskatchewan
ZIP/Postal Code
S9A 0V6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 7H9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
Country
India
Facility Name
Pfizer Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 012
Country
India
Facility Name
Pfizer Investigational Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600116
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632002
Country
India
Facility Name
Pfizer Investigational Site
City
Alytus
ZIP/Postal Code
LT-4580
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-3021
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-5800
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Isidro
State/Province
Lima
Country
Peru
Facility Name
Pfizer Investigational Site
City
San Miguel
State/Province
Lima
Country
Peru
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
107066
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661103&StudyName=A%20Multicenter%2C%20Randomized%2C%20Double-Blind%2C%20Double-Dummy%20Trial%20of%20Azithromycin%20SR%20Compared%20With%20Levofloxacin%20for%20the%20Treatment%20of%20Mild%20to
Description
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Learn more about this 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

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