Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01224626
First received: October 18, 2010
Last updated: May 29, 2012
Last verified: May 2012
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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 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 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 May 21, 2013