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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014