Xydalba Utilization Registry in France

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: Xydalba

• Registration Number: NCT03726216
• Lead Sponsor: Correvio International Sarl

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.

Study Timeline

• Study Start: 2018-09-06
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Primary Completion: 2020-04-28
• Status Verified: 2020-07
• Study Completion: 2020-10-28
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
use of Xydalba, >18 years	Xydalba	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

Primary Outcome Measures

Name	Time	Method
Clinical response	30 days	Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis

Secondary Outcome Measures

Name	Time	Method
Adverse Events, Adverse Drug Reactions and Special Situations	30 days
Clinical response by diagnosis	30 days	Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
Time from Xydalba treatment onset to clinical response	30 days

Trial Locations

Locations (15)

Centre Hospitalier de Mont de Marsan; 🇫🇷 Mont-de-Marsan, France

Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales; 🇫🇷 Ajaccio, France

CHU GRENOBLE, Maladies infectieuses et tropicales; 🇫🇷 Grenoble, France

Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit; 🇫🇷 Rennes, France

Centre hospitalier universitaire de Nice; 🇫🇷 Nice, France

CHU de Nantes; 🇫🇷 Nantes, France

Centre hospitalier régional et universitaire de Nancy; 🇫🇷 Nancy, France

CHU Bordeaux Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Raymond-Poincaré; 🇫🇷 Garches, France

Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales; 🇫🇷 Lyon, France

Hôpital Ambroise-Paré,Maladies infectieuses; 🇫🇷 Paris, France

Centre Hospitalier Universitaire de Nîmes (CHU); 🇫🇷 Nîmes, France

Centre hospitalier universitaire de Saint-Étienne; 🇫🇷 Saint-Étienne, France

Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur; 🇫🇷 Tourcoing, France

Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André; 🇫🇷 Bordeaux, France