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

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.
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- 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 TitleZyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
Official TitleZyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)
Brief SummaryTo 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe patients who are prescribed to Zyvox (linezolid).
ConditionVancomycin Resistance Enterococcus Faecium
InterventionDrug: Zyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Other Name: linezolid, Zyvox
Study Groups/CohortsZyvox (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 StatusCompleted
Actual Enrollment
 (submitted: May 29, 2012)
41
Original Estimated Enrollment
 (submitted: October 19, 2010)
20
Actual Study Completion DateApril 2011
Actual Primary Completion DateApril 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01224626
Other Study ID NumbersA5951139
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

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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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