Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study (DART)
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|ClinicalTrials.gov Identifier: NCT02991131|
Recruitment Status : Terminated (Company decision)
First Posted : December 13, 2016
Last Update Posted : October 2, 2019
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|Condition or disease||Intervention/treatment|
|Skin Disease, Infectious||Drug: Tedizolid (Sivextro, BAY1192631) Drug: Linezolid|
|Study Type :||Observational|
|Actual Enrollment :||108 participants|
|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|
Hospitalized ABSSSI patients treated with tedizolid
Drug: Tedizolid (Sivextro, BAY1192631)
Hospitalized ABSSSI patients treated with linezolid
- 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.
- Number of participants with adverse events or safety-relevant changes in laboratory parameters [ Time Frame: Up to 1 month ]
- Number of participants with investigator-assessed clinical response [ Time Frame: Up to 1 month ]
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|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|
- 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.
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients who have been enrolled in this study before.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991131
|Multiple Locations, Mexico|
|Multiple Locations, Russian Federation|
|Multiple Locations, Singapore|
|Study Director:||Bayer Study Director||Bayer|
|Other Study ID Numbers:||
SX1601 ( Other Identifier: Company Internal )
|First Posted:||December 13, 2016 Key Record Dates|
|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|
Acute bacterial skin infection
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Methicillin resistant Staphylococcus aureus (MRSA)
Skin Diseases, Bacterial
Skin Diseases, Infectious
Bacterial Infections and Mycoses
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action