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Trial record 1 of 1 for:    NCT01224626
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Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)

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ClinicalTrials.gov Identifier: NCT01224626
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : July 2, 2012
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 18, 2010
First Posted Date October 20, 2010
Results First Submitted Date March 28, 2012
Results First Posted Date July 2, 2012
Last Update Posted Date July 2, 2012
Study Start Date May 2006
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2012)
  • Number of Participants With Adverse Drug Reactions. [ Time Frame: Baseline to 8 weeks ]
    All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported as adverse events. Definition of adverse drug reaction was treatment related adverse events which were evaluated in company with the causal relationship to the investigational product.
  • Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment. [ Time Frame: Baseline to 8 weeks ]
    Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, laboratory test and investigator judgement, at the end of observation period. Clinical rating (cure/improved/not cured/unable to evaluate) was carried out. Definition of cured was disappearance of clinical symptom and/or Laboratory test abnormality. Definition of improved was improvement in clinical symptoms and/or laboratory test abnormality.
Original Primary Outcome Measures
 (submitted: October 19, 2010)
  • The frequency of treatment related adverse events. [ Time Frame: 28 days ]
  • The proportion of responders to Zyvox (linezolid) treatment. [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT01224626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 29, 2012)
Adverse Drug Reactions Unlisted in Japanese Package Insert. [ Time Frame: Baseline to 8 weeks ]
The adverse drug reactions that have not been included in Japanese package insert.
Original Secondary Outcome Measures
 (submitted: October 19, 2010)
Treatment unlisted adverse events in Japanese Package Insert. [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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