Xydalba Utilization Registry in France

Summary

Participation Requirements

Description

OBJECTIVES The objectives of this registry are as follows: To determine the following characteristics in patients who received intravenous Xydalba administration: Patient characteristics. Disease characteristics. Pathogen characteristics. To characterize the usage of Xydalba. To characterize the pat...

OBJECTIVES The objectives of this registry are as follows: To determine the following characteristics in patients who received intravenous Xydalba administration: Patient characteristics. Disease characteristics. Pathogen characteristics. To characterize the usage of Xydalba. To characterize the patient's residence and, in hospitalized patients, the lengths of hospital and intensive care unit (ICU) stays, and the destination upon hospital discharge. To assess the response of Xydalba treatment, based on clinician determination. To characterize the major healthcare resource utilization (HRU) of patients treated with Xydalba. REGISTRY DESIGN: This is a multicenter, prospective registry of adult patients treated with Xydalba in France. All Adverse events (AEs) (serious and non-serious; special situations; related and not-related, collected prospectively or retrospectively) will be recorded in the eCRF. Treatment related AEs and SAEs will be reported to the healthcare authorities, as requested by local regulations and according to current Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2). TEST PRODUCT (S), DOSE, AND MODE OF ADMINISTRATION Xydalba (dalbavancin) as prescribed by the physician according to clinical practice. RATIONALE: This prospective registry is designed to capture information about the clinical use of Xydalba, its safety and effectiveness, characteristics of the patient, disease, pathogen, clinical course, treatment course, and hospitalization. This registry will capture the data in real world setting on patients who received Xydalba.

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