This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S...
Date First Received: May 2, 2002
Last Updated: July 2, 2007
Verified by: Pfizer, July 2007
Clinical Trial Phase: Phase 3 | Start Date: December 2001
Overall Status: Completed
Estimated Enrollment: 230
Brief Summary
Official Title: “Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study”
Condition Keyword(s):
Intervention(s):
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Antibiotic
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
- Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.
- 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.
Inclusion Criteria:
Exclusion Criteria:
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
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
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