An observational study in Bacterial Infections, sponsored by Correvio International Sarl. Completed at 15 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Correvio International Sarl · Observational
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.
OBJECTIVES
The objectives of this registry are as follows:
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.
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 151 is below the median of 200 across 229 observational studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Correvio International Sarl is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The registry will capture the data in real world setting on patients who received at least one does of Xydalba.
Exclusion Criteria:
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
Also known as: Dalbavancine
Clinical response
Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
Time frame: 30 days
Clinical response by diagnosis
Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)
Time frame: 30 days
Clinical response by diagnosis
Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
Time frame: 30 days
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)
Dose(s) of Xydalba in mg per infusion
Time frame: 30 days
Number of Xydalba Infusions
number of Infusions given
Time frame: 30 days
Length of Xydalba Infusions
length of Infusions in minutes
Time frame: 30 days
Days of Xydalba treatment
number of Days of treatment
Time frame: 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
Time frame: 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
Time frame: 30 days
Prior Antibiotic Therapies
Descriptive summary of other antibiotic therapies received
Time frame: 30 days
Reason for discontinuation
descriptive listing of type of reasons
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Correvio International Sarl