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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02991131 |
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Date of registration:
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09/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study
DART |
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Scientific title:
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DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy." |
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Date of first enrolment:
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December 17, 2016 |
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Target sample size:
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108 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02991131 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Brazil
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Colombia
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Mexico
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Philippines
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Russian Federation
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Saudi Arabia
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Singapore
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United Arab Emirates
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Skin Disease, Infectious
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Intervention(s)
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Drug: Linezolid
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Drug: Tedizolid (Sivextro, BAY1192631)
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Primary Outcome(s)
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Number of treatment days
[Time Frame: Up to 1 month]
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Secondary Outcome(s)
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Number of participants with adverse events or safety-relevant changes in laboratory parameters
[Time Frame: Up to 1 month]
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Secondary ID(s)
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18299
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SX1601
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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