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

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NCT00035269

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Study Location
Research Center
Los Angeles, California, 90033, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial InfectionsNew Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
NCT00035269
  1. Los Angeles, California
  2. Jacksonville, Florida
  3. Naples, Florida
  4. Savannah, Georgia
  5. Springfield, Illinois
  6. Baton Rouge, Louisiana
  7. Baltimore, Maryland
  8. Ann Arbor, Michigan
  9. Royal Oak, Michigan
  10. Springfield, Missouri
  11. Hackensack, New Jersey
  12. Newark, New Jersey
  13. Somerville, New Jersey
  14. Staten Island, New York
  15. Stony Brook, New York
  16. Columbus, Ohio
  17. Zanesville, Ohio
  18. Fleetwood, Pennsylvania
  19. Hershey, Pennsylvania
  20. Ninety Six, South Carolina
  21. Spartanburg, South Carolina
  22. Harrogate, Tennessee
  23. Jackson, Tennessee
  24. Knoxville, Tennessee
  25. Memphis, Tennessee
  26. Memphis, Tennessee
  27. Memphis, Tennessee
  28. Nashville, Tennessee
  29. Dallas, Texas
  30. Houston, Texas
  31. Lubbock, Texas
  32. Charlottesville, Virginia
  33. Richmond, Virginia
  34. Seattle, Washington
  35. Bratislava,
  36. Mataro, Barcelona
  37. Mostoles, Madrid
  38. Barcelona,
  39. Barcelona,
  40. Barcelona,
  41. Girona,
  42. Madrid,
  43. Madrid,
  44. Madrid,
  45. Kaohsiung,
  46. Taoyuan,
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pneumonia, Pneumococcal
  • Community Acquired Infections
  • Gram-positive Bacterial Infections
Intervention  ICMJE Drug: Antibiotic
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2007)		230
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00035269
Other Study ID Numbers  ICMJE M12600071
A5951056
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date April 2011

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