stop_circleTerminated/Withdrawn

Skin disease, infectious

Bayer Identifier:

18299

ClinicalTrials.gov Identifier:

NCT02991131

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A global Observational Study

Trial purpose

This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
    - Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician’s routine treatment practice.
    - Signed informed consent.
  • - Patients participating in an investigational program with interventions outside of routine clinical practice.
    - Patients who have been enrolled in this study before.

Trial summary

Enrollment Goal
108
Trial Dates
December 2016 - November 2018
Phase
N/A
Could I Receive a placebo
No
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Many Locations, Mexico
Terminated
Many Locations, Russia
Terminated
Many Locations, Singapore

Primary Outcome

  • Number of treatment days
    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.
    date_rangeTime Frame:
    Up to 1 month
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events or safety-relevant changes in laboratory parameters
    date_rangeTime Frame:
    Up to 1 month
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A global ObseRvational STudy."
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A