Clinical Trial: Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."

Brief Summary: This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intends to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

Detailed Summary: The primary objective in this study is to assess the treatment duration in the real life in the 2 cohorts consisting of patients treated by 200 mg once daily IV/ PO tedizolid or treated by 600 mg twice daily IV/PO (Intravenous/ per oral) linezolid.
Sponsor: Bayer

Current Primary Outcome: The mean number of days that patients are treated in real life in the 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO linezolid [ Time Frame: Up to 1 month ]

Duration of treatment is defined as the time interval from date of first administration of tedizolid or linezolid to the date of permanent discontinuation of tedizolid or linezolid, respectively.

The treatment is according to the recommendations written in the local product information.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with adverse events [ Time Frame: Up to 1 month ]
  • Number of participants with investigator-assessed clinical response [ Time Frame: Up to 1 month ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: December 9, 2016
Date Started: January 13, 2017
Date Completion: February 15, 2019
Last Updated: May 17, 2017
Last Verified: May 2017