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

Skin Disease, Infectious Clinical Trial

— DART  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02991131
• Other study ID #: 18299
• Secondary ID: SX1601
• Status: Terminated
• Start date: December 17, 2016
• Est. completion date: November 21, 2018

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Disease, Infectious
• Skin Diseases
• Skin Diseases, Bacterial
• Skin Diseases, Infectious

Intervention

Drug:
• Tedizolid (Sivextro, BAY1192631)
Antibiotic
• Linezolid
Antibiotic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Mexico,  Russian Federation,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with investigator-assessed clinical response		Up to 1 month
Primary	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	Number of participants with adverse events or safety-relevant changes in laboratory parameters		Up to 1 month