Back to resultsNew Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Primary Purpose
Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Pneumococcal focused on measuring Pharmacia
Eligibility Criteria
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia. The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment. Exclusion Criteria: Patients cannot have taken more than one day of another antibiotic before entering this study. Patients with HIV and a low CD4 count are excluded.
Sites / Locations
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Outcomes
Primary Outcome Measures
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
Secondary Outcome Measures
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035269
Brief Title
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Official Title
Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
Keywords
Pharmacia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Primary Outcome Measure Information:
Title
To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).
Title
Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.
Secondary Outcome Measure Information:
Title
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.
Inclusion Criteria:
Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.
The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.
Exclusion Criteria:
Patients cannot have taken more than one day of another antibiotic before entering this study.
Patients with HIV and a low CD4 count are excluded.
Facility Information:
Facility Name
Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Research Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31416
Country
United States
Facility Name
Research Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Research Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Research Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Research Center
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Research Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Research Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Research Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Research Center
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Research Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Research Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Research Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Center
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Research Center
City
Fleetwood
State/Province
Pennsylvania
ZIP/Postal Code
19522
Country
United States
Facility Name
Research Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Research Center
City
Ninety Six
State/Province
South Carolina
ZIP/Postal Code
29666
Country
United States
Facility Name
Research Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Research Center
City
Harrogate
State/Province
Tennessee
ZIP/Postal Code
37752-0078
Country
United States
Facility Name
Research Center
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Research Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104-3499
Country
United States
Facility Name
Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Research Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Research Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Research Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Research Center
City
Bratislava
Country
Slovakia
Facility Name
Research Center
City
Mataro
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain
Facility Name
Research Center
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Research Center
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Research Center
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Center
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Center
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Research Center
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Center
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Center
City
Madrid
ZIP/Postal Code
28923
Country
Spain
Facility Name
Research Center
City
Kaohsiung
Country
Taiwan
Facility Name
Research Center
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
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