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

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	July 2, 2007
Start Date ^ICMJE	December 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: July 2, 2007)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00035269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 2, 2007)	To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	New Antibiotic to Treat Patients With Community-Acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Official Title ^ICMJE	Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study
Brief Summary	This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pneumonia, Pneumococcal Community Acquired Infections Gram-Positive Bacterial Infections
Intervention ^ICMJE	Drug: Antibiotic
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	230
Completion Date	May 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	13 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Slovakia, Spain, Taiwan

Administrative Information
NCT ID ^ICMJE	NCT00035269
Responsible Party
Study ID Numbers ^ICMJE	M12600071, A5951056
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	July 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP