Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan

NCT00150332

Last updated date
Study Location
Pfizer Investigational Site
Kamogawa, Chiba, 296-0041, Japan
Contact
1-800-718-1021

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

- infection due to methicillin-resistant Staphylococcus aureus

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


- hypersensitivity to linezolid

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Nosocomial InfectionsLinezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan NCT00150332
  1. Kamogawa, Chiba
  2. Onga-gun, Fukuoka
  3. Sappopro, Hokkaido
  4. Sapporo, Hokkaido
  5. Moriya, Ibaraki
  6. Yokohama, Kanagawa
  7. Isahaya, Nagasaki
  8. Kurashiki, Okayama
  9. Kurashiki, Okayama
  10. Suita, Osaka
  11. Iruma-gun, Saitama
  12. Kodaira, Tokyo
  13. Fukuoka,
  14. Fukuoka,
  15. Hiroshima,
  16. Hiroshima,
  17. Kyoto,
  18. Nagasaki,
  19. Okayama,
  20. Okayama,
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
Official Title  ICMJE Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial
Brief Summary Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan
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 Infections, Nosocomial
Intervention  ICMJE Drug: linezolid
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: May 9, 2011)
24
Original Enrollment  ICMJE
 (submitted: September 6, 2005)
20
Actual Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

  • hypersensitivity to linezolid
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150332
Other Study ID Numbers  ICMJE M12600067
A5951054
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

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