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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vancomycin Resistance Enterococcus Faecium

Intervention: Zyvox (linezolid) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

Official title: Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)

Study design: Observational Model: Case-Only, Time Perspective: Retrospective

Primary outcome:

Number of Participants With Adverse Drug Reactions.

Number of Participants Categorized as Responders (Cure and Improved) to Zyvox (Linezolid) Treatment.

Secondary outcome: Adverse Drug Reactions Unlisted in Japanese Package Insert.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2006
Last updated: May 29, 2012

Page last updated: August 23, 2015

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