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”

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

Intervention(s) in this Clinical Trial

• Drug: Antibiotic

Primary 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 Measures

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

• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00035269

Study ID Number: M12600071

ClinicalTrials.gov Identifier: NCT00035269

Health Authority: United States: Food and Drug Administration