Xydalba Utilization Registry in Germany
- Registration Number
- NCT03696901
- Lead Sponsor
- Correvio International Sarl
- Brief Summary
This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in Germany. 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 and retrospective registry of adult patients treated with Xydalba in Germany.
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 and retrospective 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description use of Xydalba, >18 years Xydalba Male and female patients, ≥18 years of age at the time of receipt of Xydalba. Patients who received at least one Xydalba administration in Germany
- Primary Outcome Measures
Name Time Method Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis Day of first dose
- Secondary Outcome Measures
Name Time Method Time from Xydalba treatment onset to clinical response up to 30 days after first dose Adverse Events, Adverse Drug Reactions and Special Situations up to 30 days after first dose Clinical response at 30 days after first dose Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)
Clinical response by diagnosis at 30 days after first dose Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
Trial Locations
- Locations (7)
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Martin-Luther-Universität Halle-Wittenberg
🇩🇪Halle/Saale, Germany
Universitätsklinikum Essen / Klinik für Infektiologie
🇩🇪Essen, Germany
Universitätsklinikum Regensburg /Stabsstelle Infektiologie
🇩🇪Regensburg, Germany
Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin
🇩🇪Rostock, Germany
Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene
🇩🇪München, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany