Xydalba Utilization Registry in Germany

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

May 9, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

Xydalba Utilization Registry in Germany

Official Title ^ICMJE

Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba

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.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

150

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2020

Estimated Primary Completion Date

June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria A patient must meet all of the following criteria to be eligible for participation in the study. 1. Male and female patient, ≥18 years of age at the time of receipt of Xydalba. 2. The patient received at least one infusion of Xydalba. 3. Patient signed the consent form Exclusion Criteria A patient who meets the following criterion is not eligible for participation in the study. 1. The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Correvio

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Kiran Bhirangi, MBBS FRCS I Correvio

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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