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

This study has been completed.

First Received on May 2, 2002. Last Updated on April 25, 2011 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00035269

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 III

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:

MedlinePlus related topics: Antibiotics Bacterial Infections Pneumonia

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 February 09, 2012