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

Bayer

Status

Terminated

Conditions

Skin Disease, Infectious

Treatments

Drug: Tedizolid (Sivextro, BAY1192631)

Drug: Linezolid

Study type

Observational

Funder types

Industry

Identifiers

NCT02991131

SX1601 (Other Identifier)

18299

Details and patient eligibility

About

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.

Full description

The primary objective of this study was to assess the treatment duration in the real life in 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.