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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Disease, Infectious

Intervention / Treatment
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* Drug: Tedizolid (Sivextro, BAY1192631)
* Drug: Linezolid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tedizolid<br>Hospitalized ABSSSI patients treated with tedizolid | Drug: Tedizolid (Sivextro, BAY1192631)<br>* Antibiotic<br>|
| Linezolid<br>Hospitalized ABSSSI patients treated with linezolid | Drug: Linezolid<br>* Antibiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events or safety-relevant changes in laboratory parameters |  | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cellulitis, Acute bacterial skin infection, Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Abscess, Erysipelas, Wound infection, Methicillin resistant Staphylococcus aureus (MRSA)