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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00035269
First received: May 2, 2002
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Pneumonia, Pneumococcal
Community Acquired Infections
Gram-positive Bacterial Infections
 Drug: Antibiotic
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome 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 Outcome Measures:
  • To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.

Enrollment: 230
Study Start Date: December 2001
Study Completion Date: May 2003
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035269

  Show 46 Study Locations
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00035269     History of Changes
Other Study ID Numbers: M12600071, A5951056
Study First Received: May 2, 2002
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacia

Additional relevant MeSH terms:
Bacterial Infections
Pneumonia
Gram-Positive Bacterial Infections
Pneumonia, Pneumococcal
Community-Acquired Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Pneumococcal Infections
Streptococcal Infections
Pneumonia, Bacterial
Infection
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013