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

Phase 3

Completed

• Conditions: Pneumonia, Pneumococcal; Community Acquired Infections; Gram-positive Bacterial Infections

• Registration Number: NCT00035269
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Study Completion: 2003-05
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-25
• Last Update Posted: 2011-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.

Trial Locations

Locations (1)

Research Center; 🇨🇳 Taoyuan, Taiwan