Xydalba Utilization Registry in Germany
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|ClinicalTrials.gov Identifier: NCT03696901|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
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.
|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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba|
|Estimated Study Start Date :||October 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 Germany
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: Dalbavancin
- Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis [ Time Frame: Day of first dose ]
- Clinical response [ Time Frame: at 30 days after first dose ]Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)
- Clinical response by diagnosis [ Time Frame: at 30 days after first dose ]Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
- Time from Xydalba treatment onset to clinical response [ Time Frame: up to 30 days after first dose ]
- Adverse Events, Adverse Drug Reactions and Special Situations [ Time Frame: up to 30 days after first dose ]
- Xydalba Treatment dose(s) [ Time Frame: up to 30 days after first dose ]Dose(s) of Xydalba in mg per infusion
- Number of Xydalba Infusions [ Time Frame: up to 30 days after first dose ]number of Infusions given
- Length of Xydalba Infusions [ Time Frame: up to 30 days after first dose ]length of Infusions in minutes
- Days of Xydalba treatment [ Time Frame: up to 30 days after first dose ]number of Days of treatment
- Percentage of monotherapy vs. concurrent therapy [ Time Frame: up to 30 days after first dose ]% 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: up to 30 days after first dose ]% 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: from the time of the primary specified infectious disease diagnosis until Xydalba treatment ]Descriptive summary of other antibiotic therapies received
- Reason for discontinuation [ Time Frame: up to 30 days after first dose ]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): NCT03696901
|Contact: Shanti Amann, Dr rer nat||0049 621 700 95 firstname.lastname@example.org|
|Contact: Nathalie Dunkel||+41 (0) 22 907 79 email@example.com|
|Universitätsklinikum Essen / Klinik für Infektiologie||Not yet recruiting|
|Contact: Sebastian Dolff, PD Dr. med.|
|Universitätsklinikum Leipzig / Institut für Medizinische Mikrobiologie und Infektionsepidemiologie||Not yet recruiting|
|Contact: Arne C Rodloff, Prof Dr med.|
|Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene||Not yet recruiting|
|Contact: Beatrice Grabein, Dr. med.|
|Universitätsklinikum Regensburg /Stabsstelle Infektiologie||Not yet recruiting|
|Contact: Frank Hanses, PD Dr. med.|
|Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin||Not yet recruiting|
|Contact: Micha Löbermann, PD Dr. med.|
|Study Director:||Kiran Bhirangi, MBBS FRCS I||Correvio|