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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991131
Recruitment Status : Terminated (Company decision)
First Posted : December 13, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Infections
Drug Information available for: Linezolid

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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.

Information from the National Library of Medicine

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


Locations
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Mexico
Multiple Locations, Mexico
Russian Federation
Multiple Locations, Russian Federation
Singapore
Multiple Locations, Singapore
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02991131    
Other Study ID Numbers: 18299
SX1601 ( Other Identifier: Company Internal )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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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:
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Infection
Communicable Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases
Bacterial Infections
Linezolid
Tedizolid
Tedizolid phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action