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| Name | Class |
|---|---|
| Universal Medical Group | UNKNOWN |
| PrimeVigilance | INDUSTRY |
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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.
OBJECTIVES
The objectives of this registry are as follows:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use of Xydalba, >18 years | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xydalba | Drug | 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Xydalba Treatment dose(s) | Dose(s) of Xydalba in mg per infusion | 30 days |
| Number of Xydalba Infusions | number of Infusions given | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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The registry will capture the data in real world setting on patients who received at least one does of Xydalba.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales | Ajaccio | France | ||||
| Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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| 30 days |
| Time from Xydalba treatment onset to clinical response | 30 days |
| Adverse Events, Adverse Drug Reactions and Special Situations | 30 days |
| Length of Xydalba Infusions | length of Infusions in minutes | 30 days |
| Days of Xydalba treatment | number of Days of treatment | 30 days |
| Percentage of monotherapy vs. concurrent therapy | % of cases for which Xydalba is given as monotherapy and % of cases for which Xydalba is given as concurrent therapy | 30 days |
| Percentage first-line vs. subsequent-line monotherapy | % of cases for which Xydalba is given as first-line and % of cases for which Xydalba is given as subsequent-line | 30 days |
| Prior Antibiotic Therapies | Descriptive summary of other antibiotic therapies received | 30 days |
| Reason for discontinuation | descriptive listing of type of reasons | 30 days |
| Bordeaux |
| France |
| CHU Bordeaux Pellegrin | Bordeaux | France |
| Hôpital Raymond-Poincaré | Garches | France |
| CHU GRENOBLE, Maladies infectieuses et tropicales | Grenoble | France |
| Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales | Lyon | France |
| Centre Hospitalier de Mont de Marsan | Mont-de-Marsan | France |
| Centre hospitalier régional et universitaire de Nancy | Nancy | France |
| CHU de Nantes | Nantes | France |
| Centre hospitalier universitaire de Nice | Nice | France |
| Centre Hospitalier Universitaire de Nîmes (CHU) | Nîmes | France |
| Hôpital Ambroise-Paré,Maladies infectieuses | Paris | France |
| Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit | Rennes | France |
| Centre hospitalier universitaire de Saint-Étienne | Saint-Etienne | France |
| Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur | Tourcoing | France |