Xydalba Utilization Registry in France
Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France
1 other identifier
observational
151
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2018
CompletedFirst Submitted
Initial submission to the registry
October 29, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedJuly 20, 2021
July 1, 2020
1.6 years
October 29, 2018
July 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical response
Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
30 days
Secondary Outcomes (4)
Clinical response by diagnosis
30 days
Clinical response by diagnosis
30 days
Time from Xydalba treatment onset to clinical response
30 days
Adverse Events, Adverse Drug Reactions and Special Situations
30 days
Other Outcomes (8)
Xydalba Treatment dose(s)
30 days
Number of Xydalba Infusions
30 days
Length of Xydalba Infusions
30 days
- +5 more other outcomes
Study Arms (1)
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
Interventions
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
Eligibility Criteria
The registry will capture the data in real world setting on patients who received at least one does of Xydalba.
You may qualify if:
- 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
You may not qualify if:
- The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Correvio International Sarllead
- Universal Medical Groupcollaborator
- PrimeVigilancecollaborator
Study Sites (15)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2018
First Posted
October 31, 2018
Study Start
September 6, 2018
Primary Completion
April 28, 2020
Study Completion
October 28, 2020
Last Updated
July 20, 2021
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share