Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
NCT01224626
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
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
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
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.
Show details
- Infected subject with MRSA and other organism.
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Vancomycin Resistance Enterococcus FaeciumZyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
NCT01224626
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| 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 | |||