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

Terminated

• Conditions: Skin Disease, Infectious
• Interventions: Drug: Tedizolid (Sivextro, BAY1192631); Drug: Linezolid

• Registration Number: NCT02991131
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Study Start: 2016-12-17
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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.

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Exclusion Criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Patients who have been enrolled in this study before.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tedizolid	Tedizolid (Sivextro, BAY1192631)	Hospitalized ABSSSI patients treated with tedizolid
Linezolid	Linezolid	Hospitalized ABSSSI patients treated with linezolid

Primary Outcome Measures

Name	Time	Method
Number of treatment days	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events or safety-relevant changes in laboratory parameters	Up to 1 month