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

May 2, 2002
April 25, 2011
December 2001
Not Provided
  • 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.
Not Provided
Complete list of historical versions of study NCT00035269 on ClinicalTrials.gov Archive Site
To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.
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New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pneumonia, Pneumococcal
  • Community Acquired Infections
  • Gram-positive Bacterial Infections
Drug: Antibiotic
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
May 2003
Not Provided

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Slovakia,   Spain,   Taiwan
 
NCT00035269
M12600071, A5951056
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Pfizer
Not Provided
Not Provided
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP