New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)

Condition(s) targeted: Pneumonia, Pneumococcal; Community Acquired Infections; Gram-positive Bacterial Infections

Intervention: Antibiotic (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)

Official title: Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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: To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Research Center, Bratislava, Slovakia

Research Center, Barcelona 08025, Spain

Research Center, Barcelona 08036, Spain

Research Center, Barcelona 08907, Spain

Research Center, Girona 17007, Spain

Research Center, Madrid 28034, Spain

Research Center, Madrid 28046, Spain

Research Center, Madrid 28923, Spain

Research Center, Kaohsiung, Taiwan

Research Center, Taoyuan, Taiwan

Research Center, Mataro, Barcelona 08304, Spain

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, Mostoles, Madrid 28935, Spain

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

Research Center, 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

Starting date: December 2001
Last updated: April 25, 2011