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

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

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.

Study Overview

• Status: Terminated
• Conditions: Skin Disease, Infectious
• Intervention / Treatment: Drug: Tedizolid (Sivextro, BAY1192631); Drug: Linezolid

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 Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Mexico
  • Multiple Locations, Mexico
• Russian Federation
  • Multiple Locations, Russian Federation
• Singapore
  • Multiple Locations, Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tedizolid; Hospitalized ABSSSI patients treated with tedizolid	Drug: Tedizolid (Sivextro, BAY1192631); Antibiotic
Linezolid; Hospitalized ABSSSI patients treated with linezolid	Drug: Linezolid; Antibiotic

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with investigator-assessed clinical response	Up to 1 month

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2016
• Primary Completion (ACTUAL): November 21, 2018
• Study Completion (ACTUAL): November 21, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (ESTIMATE): December 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Abscess; Wound infection; Erysipelas; Cellulitis; Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Acute bacterial skin infection; Methicillin resistant Staphylococcus aureus (MRSA)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Skin Diseases, Infectious; Skin Diseases; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid; Tedizolid; Tedizolid phosphate
• Other Study ID Numbers: 18299; SX1601 (OTHER: Company Internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No