New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
2 other identifiers
interventional
230
4 countries
46
Brief Summary
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2001
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedApril 26, 2011
April 1, 2011
May 2, 2002
April 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (46)
Research Center
Los Angeles, California, 90033, United States
Research Center
Jacksonville, Florida, 32209, United States
Research Center
Naples, Florida, 34102, United States
Research Center
Savannah, Georgia, 31416, United States
Research Center
Springfield, Illinois, 62701, United States
Research Center
Baton Rouge, Louisiana, 70808, United States
Research Center
Baltimore, Maryland, 21201, United States
Research Center
Ann Arbor, Michigan, 48197, United States
Research Center
Royal Oak, Michigan, 48073, United States
Research Center
Springfield, Missouri, 65807, United States
Research Center
Hackensack, New Jersey, 07601, United States
Research Center
Newark, New Jersey, 07102, United States
Research Center
Somerville, New Jersey, 08876, United States
Research Center
Staten Island, New York, 10305, United States
Research Center
Stony Brook, New York, 11794, United States
Research Center
Columbus, Ohio, 43215, United States
Research Center
Zanesville, Ohio, 43701, United States
Research Center
Fleetwood, Pennsylvania, 19522, United States
Research Center
Hershey, Pennsylvania, 17033, United States
Research Center
Ninety Six, South Carolina, 29666, United States
Research Center
Spartanburg, South Carolina, 29307, United States
Research Center
Harrogate, Tennessee, 37752-0078, United States
Research Center
Jackson, Tennessee, 38301, United States
Research Center
Knoxville, Tennessee, 37920, United States
Research Center
Memphis, Tennessee, 38104-3499, United States
Research Center
Memphis, Tennessee, 38120, United States
Research Center
Memphis, Tennessee, 38163, United States
Research Center
Nashville, Tennessee, 37205, United States
Research Center
Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
Research Center
Lubbock, Texas, 79430, United States
Research Center
Charlottesville, Virginia, 22902, United States
Research Center
Richmond, Virginia, 23294, United States
Research Center
Seattle, Washington, 98108, United States
Research Center
Bratislava, Slovakia
Research Center
Barcelona, Barcelona, 08025, Spain
Research Center
Barcelona, Barcelona, 08036, Spain
Research Center
Barcelona, Barcelona, 08907, Spain
Research Center
Mataró, Barcelona, 08304, Spain
Research Center
Girona, Girona, 17007, Spain
Research Center
Madrid, Madrid, 28034, Spain
Research Center
Madrid, Madrid, 28046, Spain
Research Center
Madrid, Madrid, 28923, Spain
Research Center
Móstoles, Madrid, 28935, Spain
Research Center
Kaohsiung City, Taiwan
Research Center
Taoyuan District, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2002
First Posted
May 3, 2002
Study Start
December 1, 2001
Study Completion
May 1, 2003
Last Updated
April 26, 2011
Record last verified: 2011-04