Xydalba Utilization Registry in France
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|ClinicalTrials.gov Identifier: NCT03726216|
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
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.
|Condition or disease||Intervention/treatment|
|Bacterial Infections||Drug: Xydalba|
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.
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.
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 [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France|
|Actual Study Start Date :||September 6, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
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
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 Name: Dalbavancine
- Clinical response [ Time Frame: 30 days ]Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
- Clinical response by diagnosis [ Time Frame: 30 days ]Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)
- Clinical response by diagnosis [ Time Frame: 30 days ]Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
- Time from Xydalba treatment onset to clinical response [ Time Frame: 30 days ]
- Adverse Events, Adverse Drug Reactions and Special Situations [ Time Frame: 30 days ]
- Xydalba Treatment dose(s) [ Time Frame: 30 days ]Dose(s) of Xydalba in mg per infusion
- Number of Xydalba Infusions [ Time Frame: 30 days ]number of Infusions given
- Length of Xydalba Infusions [ Time Frame: 30 days ]length of Infusions in minutes
- Days of Xydalba treatment [ Time Frame: 30 days ]number of Days of treatment
- Percentage of monotherapy vs. concurrent therapy [ Time Frame: 30 days ]% of cases for which Xydalba is given as monotherapy and % of cases for which Xydalba is given as concurrent therapy
- Percentage first-line vs. subsequent-line monotherapy [ Time Frame: 30 days ]% of cases for which Xydalba is given as first-line and % of cases for which Xydalba is given as subsequent-line
- Prior Antibiotic Therapies [ Time Frame: 30 days ]Descriptive summary of other antibiotic therapies received
- Reason for discontinuation [ Time Frame: 30 days ]descriptive listing of type of reasons
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726216
|Contact: Nathalie Dunkel, MSc||+41 (0) 22 907 79 firstname.lastname@example.org|
|Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales||Not yet recruiting|
|Contact: Bernard Castan, MD|
|Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André||Active, not recruiting|
|CHU Bordeaux Pellegrin||Active, not recruiting|
|Hôpital Raymond-Poincaré||Active, not recruiting|
|CHU GRENOBLE, Maladies infectieuses et tropicales||Recruiting|
|Contact: Jean-Paul STAHL, MD|
|Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales||Active, not recruiting|
|Centre Hospitalier de Mont de Marsan||Recruiting|
|Contact: Gabriela Illes, MD|
|Centre hospitalier régional et universitaire de Nancy||Not yet recruiting|
|Contact: François Goehringer, MD|
|CHU de Nantes||Not yet recruiting|
|Contact: Davide Boutoille, MD|
|Centre hospitalier universitaire de Nice||Active, not recruiting|
|Centre Hospitalier Universitaire de Nîmes (CHU)||Recruiting|
|Contact: Catherine Lechiche, MD|
|Hôpital Ambroise-Paré,Maladies infectieuses||Active, not recruiting|
|Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit||Recruiting|
|Contact: Pierre Tattevin, MD, PhD|
|Centre hospitalier universitaire de Saint-Étienne||Active, not recruiting|
|Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur||Recruiting|
|Contact: Eric Senneville, MD|