Trial Condition(s):
Skin disease, infectious
Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A global Observational Study (DART)
Bayer Identifier:
18299
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Mexico | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many Locations, Russia | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Many Locations, Singapore | Status Terminated | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A global ObseRvational STudy."
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Number of treatment daysDuration 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.Timeframe: Up to 1 month
Secondary Outcome
- Number of participants with adverse events or safety-relevant changes in laboratory parametersTimeframe: Up to 1 month
Additional Information
Not Available
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