Xydalba Utilization Registry in France

Study Overview
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Brief Summary
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This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in France. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland. Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called gram positive bacteria) which cause the disease. Active ingredients against bacteria are also called antibiotics. Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.

Detailed Description
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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.

Official Title
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Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: Xydalba


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patient associate to a social protection scheme, ≥18 years of age at the time of receipt of Xydalba The patient received at least one infusion of Xydalba Patient signed the consent form Exclusion Criteria: The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| use of Xydalba, >18 years<br>Male and female patients, ≥18 years of age at the time of receipt of Xydalba. Patients who received at least one Xydalba administration in France | Drug: Xydalba<br>* Information will be recorded about Xydalba administration (e.g. dose(s), number of infusions, length of infusions, dates or schedule of administration, sites of administration [e.g. hospital, ICU]), and reason for discontinuation, including response to treatment to assess whether the patient was clinically improving when Xydalba was discontinued<br>* Other names: Dalbavancine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response by diagnosis | Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable) | 30 days | 
| Clinical response by diagnosis | Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis) | 30 days | 
| Time from Xydalba treatment onset to clinical response |  | 30 days | 
| Adverse Events, Adverse Drug Reactions and Special Situations |  | 30 days |