Xydalba Utilization Registry in France

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726216
• Other study ID #: DAL-REG01-FRA
• Status: Completed
• Start date: September 6, 2018
• Est. completion date: October 28, 2020

Study information

• Verified date: July 2020
• Source: Correvio International Sarl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 28, 2020
• Est. primary completion date: April 28, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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

Locations

Country	Name	City	State
France	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-Étienne
France	Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur	Tourcoing

Sponsors (3)

Lead Sponsor	Collaborator
Correvio International Sarl	PrimeVigilance, Universal Medical Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Xydalba Treatment dose(s)	Dose(s) of Xydalba in mg per infusion	30 days
Other	Number of Xydalba Infusions	number of Infusions given	30 days
Other	Length of Xydalba Infusions	length of Infusions in minutes	30 days
Other	Days of Xydalba treatment	number of Days of treatment	30 days
Other	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
Other	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
Other	Prior Antibiotic Therapies	Descriptive summary of other antibiotic therapies received	30 days
Other	Reason for discontinuation	descriptive listing of type of reasons	30 days
Primary	Clinical response	Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis	30 days
Secondary	Clinical response by diagnosis	Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)	30 days
Secondary	Clinical response by diagnosis	Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)	30 days
Secondary	Time from Xydalba treatment onset to clinical response		30 days
Secondary	Adverse Events, Adverse Drug Reactions and Special Situations		30 days