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

• ClinicalTrials.gov Identifier: NCT02991131
• Recruitment Status: Terminated
• First Posted: December 13, 2016
• Last Update Posted: October 2, 2019
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Skin Disease, Infectious	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 Design

• Study Type: Observational
• Actual Enrollment: 108 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."
• Actual Study Start Date: December 17, 2016
• Actual Primary Completion Date: November 21, 2018
• Actual Study Completion Date: November 21, 2018

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Number of treatment days [ Time Frame: 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 :

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

Other Outcome Measures:

1. Number of participants with investigator-assessed clinical response [ Time Frame: Up to 1 month ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients

Criteria

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.

Contacts and Locations

Locations

Mexico

Multiple Locations, Mexico

Russian Federation

Multiple Locations, Russian Federation

Singapore

Multiple Locations, Singapore

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02991131
• Other Study ID Numbers: 18299; SX1601 ( Other Identifier: Company Internal )
• First Posted: December 13, 2016
• Last Update Posted: October 2, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Acute bacterial skin infection; Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Abscess; Cellulitis; Erysipelas; Wound infection; Methicillin resistant Staphylococcus aureus (MRSA)

Additional relevant MeSH terms:

Infections; Communicable Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Disease Attributes; Pathologic Processes; Bacterial Infections; Bacterial Infections and Mycoses; Linezolid; Tedizolid; Tedizolid phosphate; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action