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OpenTrials
Completed

NCT Number: NCT01224626

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

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.

Completed

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Key information

Conditions

Vancomycin Resistance Enterococcus Faecium

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zyvox (linezolid)

Drug

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

Other names: linezolid, Zyvox

Primary outcomes

  1. Number of Participants With Adverse Drug Reactions.

    Time frame: Baseline to 8 weeks

    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.

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

    Time frame: Baseline to 8 weeks

    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 outcomes

  1. Adverse Drug Reactions Unlisted in Japanese Package Insert.

    Time frame: Baseline to 8 weeks

    The adverse drug reactions that have not been included in Japanese package insert.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2010
Registry last updated
Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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