Clinical trial NCT03726216: Xydalba Utilization Registry in France
Official title: Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
Collaborators: name: Universal Medical Group
name: PrimeVigilance
First posted: 2018-10-31
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Clinical response
timeFrame: 30 days
Secondary outcomes:
measure: Clinical response by diagnosis
timeFrame: 30 days
measure: Clinical response by diagnosis
timeFrame: 30 days
measure: Time from Xydalba treatment onset to clinical response
timeFrame: 30 days
measure: Adverse Events, Adverse Drug Reactions and Special Situations
timeFrame: 30 days
Other outcomes:
measure: Xydalba Treatment dose(s)
timeFrame: 30 days
measure: Number of Xydalba Infusions
timeFrame: 30 days
measure: Length of Xydalba Infusions
timeFrame: 30 days
measure: Days of Xydalba treatment
timeFrame: 30 days
measure: Percentage of monotherapy vs. concurrent therapy
timeFrame: 30 days
measure: Percentage first-line vs. subsequent-line monotherapy
timeFrame: 30 days
measure: Prior Antibiotic Therapies
timeFrame: 30 days
measure: Reason for discontinuation
timeFrame: 30 days
Locations:
city: Ajaccio
country: France
facility: Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André
city: Bordeaux
country: France
facility: CHU Bordeaux Pellegrin
city: Garches
country: France
facility: Hôpital Raymond-Poincaré
city: Grenoble
country: France
facility: CHU GRENOBLE, Maladies infectieuses et tropicales
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier de Mont de Marsan
city: Nancy
country: France
facility: Centre hospitalier régional et universitaire de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: Centre hospitalier universitaire de Nice
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes (CHU)
city: Paris
country: France
facility: Hôpital Ambroise-Paré,Maladies infectieuses
city: Rennes
country: France
facility: Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit
city: Saint-Étienne
country: France
facility: Centre hospitalier universitaire de Saint-Étienne
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur
Study officials:
References: