Xydalba Utilization Registry in France

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Xydalba

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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• France
  • Ajaccio, France
    • Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales
  • Bordeaux, France
    • CHU Bordeaux Pellegrin
  • Bordeaux, France
    • Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André
  • Garches, France
    • Hôpital Raymond-Poincaré
  • Grenoble, France
    • CHU GRENOBLE, Maladies infectieuses et tropicales
  • Lyon, France
    • Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales
  • Mont-de-Marsan, France
    • Centre Hospitalier de Mont de Marsan
  • Nancy, France
    • Centre Hospitalier Régional et Universitaire de Nancy
  • Nantes, France
    • CHU de Nantes
  • Nice, France
    • Centre Hospitalier Universitaire de Nice
  • Nîmes, France
    • Centre Hospitalier Universitaire de Nîmes (CHU)
  • Paris, France
    • Hôpital Ambroise-Paré,Maladies infectieuses
  • Rennes, France
    • Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit
  • Saint-Étienne, France
    • Centre Hospitalier Universitaire de Saint-Etienne
  • Tourcoing, France
    • Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry will capture the data in real world setting on patients who received at least one does of Xydalba.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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; Other Names: Dalbavancine

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Correvio International Sarl
• Collaborators: PrimeVigilance; Universal Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2018
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): October 28, 2020

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: DAL-REG01-FRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No