Xydalba Utilization Registry in France

NCT ID: NCT03726216

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 151 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-06
• Study Completion Date: 2020-10-28

Brief Summary

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

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.

Conditions

Bacterial Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Xydalba

Intervention Type: 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

Interventions

Xydalba

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

Intervention Type: DRUG

Other Intervention Names

Dalbavancine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universal Medical Group

UNKNOWN

Sponsor Role: collaborator

PrimeVigilance

INDUSTRY

Sponsor Role: collaborator

Correvio International Sarl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales

Ajaccio, , France

Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André

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

Countries

France

Other Identifiers

DAL-REG01-FRA

Identifier Type: -

Identifier Source: org_study_id