Xydalba Utilization Registry in Germany

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

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.

Study Overview

• Status: Terminated
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Xydalba

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: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany
    • Universitätsklinikum Essen / Klinik für Infektiologie
  • Gießen, Germany
    • Universitatsklinikum Gießen und Marburg GmbH
  • Halle/Saale, Germany
    • Martin-Luther-Universität Halle-Wittenberg
  • Jena, Germany
    • Universitätsklinikum Jena
  • München, Germany
    • Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene
  • Regensburg, Germany
    • Universitätsklinikum Regensburg /Stabsstelle Infektiologie
  • Rostock, Germany
    • Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry will capture the data in real world setting on patients who received at least one does of Xydalba.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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; Other Names: Dalbavancin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Clinical response	Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)	at 30 days after first dose
Clinical response by diagnosis	Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)	at 30 days after first dose
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xydalba Treatment dose(s)	Dose(s) of Xydalba in mg per infusion	up to 30 days after first dose
Number of Xydalba Infusions	number of Infusions given	up to 30 days after first dose
Length of Xydalba Infusions	length of Infusions in minutes	up to 30 days after first dose
Days of Xydalba treatment	number of Days of treatment	up to 30 days after first dose
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	up to 30 days after first dose
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	up to 30 days after first dose
Prior Antibiotic Therapies	Descriptive summary of other antibiotic therapies received	from the time of the primary specified infectious disease diagnosis until Xydalba treatment (estimated to be within 3 months of Xydalba treatment)
Reason for discontinuation	descriptive listing of type of reasons	up to 30 days after first dose

Collaborators and Investigators

• Sponsor: Correvio International Sarl
• Collaborators: PrimeVigilance; AMS Advanced Medical Services GmbH
• Investigators: Study Director: Kiran Bhirangi, MBBS FRCS I, Correvio International Sarl

Publications and helpful links

General Publications

• Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83.
• Garau J, Ostermann H, Medina J, Avila M, McBride K, Blasi F; REACH study group. Current management of patients hospitalized with complicated skin and soft tissue infections across Europe (2010-2011): assessment of clinical practice patterns and real-life effectiveness of antibiotics from the REACH study. Clin Microbiol Infect. 2013 Sep;19(9):E377-85. doi: 10.1111/1469-0691.12235. Epub 2013 May 10.
• Morbidité et mortalité des infections à bactéries multi-résistantes aux antibiotiques en France en 2012. Étude Burden BMR, rapport - Juin 2015. Saint-Maurice : Institut de veille sanitaire ; 2015. 21p. Disponible à partir de l'URL : http://www.invs.sante.fr
• Rolain JM, Abat C, Jimeno MT, Fournier PE, Raoult D. Do we need new antibiotics? Clin Microbiol Infect. 2016 May;22(5):408-15. doi: 10.1016/j.cmi.2016.03.012. Epub 2016 Mar 26.
• EMA Assessment Report 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002840/WC500183871.pdf
• Smith JR, Roberts KD, Rybak MJ. Dalbavancin: A Novel Lipoglycopeptide Antibiotic with Extended Activity Against Gram-Positive Infections. Infect Dis Ther. 2015 Sep;4(3):245-58. doi: 10.1007/s40121-015-0077-7. Epub 2015 Sep 4.
• Xydalba approval history. Drugs.com. http://www.drugs.com/history/Xydalba.html. Accessed February 3, 2016
• Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.
• Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products

Helpful Links

• European Medicines Agency

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2018
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): April 7, 2020

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Dalbavancine; Xydalba
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: DAL-REG01-GER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
   Information identifier: Xydalba
   Information comments: BfArM AWB Datenbank

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No