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

NCT01224626 | Completed Results

• 1 other identifier: A5951139
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vancomycin Resistance Enterococcus Faecium

Keywords

VRE; Japanese; Post Marketing Surveillance

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Drug Reactions.

  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.

  Baseline to 8 weeks

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

  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.

  Baseline to 8 weeks

Secondary Outcomes (1)

• Adverse Drug Reactions Unlisted in Japanese Package Insert.

  Baseline to 8 weeks

Study Arms (1)

Zyvox (linezolid)

Patients who have been treated with Zyvox (linezolid).

Drug: Zyvox (linezolid)

Interventions

Zyvox (linezolid) DRUG

Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.

Also known as: linezolid, Zyvox

Zyvox (linezolid)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients who are prescribed to Zyvox (linezolid).

You may qualify if:

• Subject to whom Zyvox (linezolid) was administered.
• Infected subject with Vancomycin resistance Enterococcus faecium.

You may not qualify if:

• Infected subject with MRSA and other organism.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Interventions

Linezolid

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 20, 2010
• Study Start: May 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 2, 2012
• Results First Posted: July 2, 2012

Record last verified: 2012-05