Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)
|ClinicalTrials.gov Identifier: NCT01224626|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : July 2, 2012
Last Update Posted : July 2, 2012
|Condition or disease||Intervention/treatment|
|Vancomycin Resistance Enterococcus Faecium||Drug: Zyvox (linezolid)|
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Zyvox (Linezolid) Special Investigation For Vancomycin-Resistant Enterococci (VRE)(Regulatory Post Marketing Commitment Plan)|
|Study Start Date :||May 2006|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Patients who have been treated with Zyvox (linezolid).
Drug: Zyvox (linezolid)
Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
Other Name: linezolid, Zyvox
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224626
|Study Director:||Pfizer CT.gov Call Center||Pfizer|