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Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

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NCT01224626

Last updated on February 15, 2020
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vancomycin Resistance Enterococcus Faecium
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject to whom Zyvox (linezolid) was administered.

- Infected subject with Vancomycin resistance Enterococcus faecium.

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

- Infected subject with MRSA and other organism.

NCT01224626
Pfizer
Completed
Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

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Descriptive Information
Brief Title Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
Official Title Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)
Brief Summary To collect the efficacy and safety information in subjects who have been treated with Zyvox (linezolid) for vancomycin resistance Enterococcus faecium infection for their appropriate use in daily practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients who are prescribed to Zyvox (linezolid).
Condition Vancomycin Resistance Enterococcus Faecium
Intervention Drug: Zyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Other Name: linezolid, Zyvox
Study Groups/Cohorts Zyvox (linezolid)
Patients who have been treated with Zyvox (linezolid).
Intervention: Drug: Zyvox (linezolid)
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 Completed
Actual Enrollment
 (submitted: May 29, 2012) 		41
Original Estimated Enrollment
 (submitted: October 19, 2010) 		20
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject to whom Zyvox (linezolid) was administered.
  • Infected subject with Vancomycin resistance Enterococcus faecium.

Exclusion Criteria:

  • Infected subject with MRSA and other organism.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01224626
Other Study ID Numbers A5951139
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012

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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