Skin Disease, Infectious
Conditions
Keywords
Acute bacterial skin infection, Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Abscess, Cellulitis, Erysipelas, Wound infection, Methicillin resistant Staphylococcus aureus (MRSA)
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.
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.
Interventions
DRUGTedizolid (Sivextro, BAY1192631)
Antibiotic
DRUGLinezolid
Antibiotic
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment days | 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
| Measure | Time frame |
|---|---|
| Number of participants with adverse events or safety-relevant changes in laboratory parameters | Up to 1 month |
Other
| Measure | Time frame |
|---|---|
| Number of participants with investigator-assessed clinical response | Up to 1 month |
Countries
Mexico, Russia, Singapore
Outcome results
None listed