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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01224626
First received: October 18, 2010
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Vancomycin Resistance Enterococcus Faecium
Drug: Zyvox (linezolid)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Drug Reactions. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse Drug Reactions Unlisted in Japanese Package Insert. [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: Yes ]
    The adverse drug reactions that have not been included in Japanese package insert.


Enrollment: 41
Study Start Date: May 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Zyvox (linezolid)
Patients who have been treated with Zyvox (linezolid).
Drug: Zyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Other Name: linezolid, Zyvox

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The patients who are prescribed to Zyvox (linezolid).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224626

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01224626     History of Changes
Other Study ID Numbers: A5951139
Study First Received: October 18, 2010
Results First Received: March 28, 2012
Last Updated: May 29, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
VRE
Japanese
Post Marketing Surveillance

Additional relevant MeSH terms:
Vancomycin
Linezolid
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014