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.
- Subject to whom Zyvox (linezolid) was administered.
- Infected subject with Vancomycin resistance Enterococcus faecium.
- Infected subject with MRSA and other organism.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 41 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2012 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
