Trial Condition(s):

Skin disease, infectious

Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A global Observational Study (DART)

Bayer Identifier:

18299

ClinicalTrials.gov Identifier:

NCT02991131

EudraCT Number:

Not Available

Terminated/Withdrawn

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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
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Phase
N/A
Could I receive a placebo?
No
Products
Sivextro (Tedizolid phosphate, BAY119-2631)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Mexico

Status
Terminated
 
Locations

Investigative Site

Many Locations, Russia

Status
Terminated
 
Locations

Investigative Site

Many Locations, Singapore

Status
Terminated
 

Trial Design