Xydalba Utilization Registry in Germany

NCT ID: NCT03696901

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2020-04-07

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.

Conditions

Bacterial Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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

Xydalba

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Dalbavancin

Eligibility Criteria

Inclusion Criteria

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

1. The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AMS Advanced Medical Services GmbH

INDUSTRY

Sponsor Role: collaborator

PrimeVigilance

INDUSTRY

Sponsor Role: collaborator

Correvio International Sarl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiran Bhirangi, MBBS FRCS I

Role: STUDY_DIRECTOR

Correvio International Sarl

Locations

Universitätsklinikum Essen / Klinik für Infektiologie

Essen, , Germany

Universitätsklinikum Gießen und Marburg GmbH

Giessen, , Germany

Martin-Luther-Universität Halle-Wittenberg

Halle, , Germany

Universitätsklinikum Jena

Jena, , Germany

Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene

München, , Germany

Universitätsklinikum Regensburg /Stabsstelle Infektiologie

Regensburg, , Germany

Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin

Rostock, , Germany

Countries

Germany

References

Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83.

Reference Type: BACKGROUND

PMID: 25859123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23663184 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27021418 (View on PubMed)

EMA Assessment Report 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002840/WC500183871.pdf

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 26341488 (View on PubMed)

Xydalba approval history. Drugs.com. http://www.drugs.com/history/Xydalba.html. Accessed February 3, 2016

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 24897082 (View on PubMed)

Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products

Reference Type: BACKGROUND

Study Documents

Document Type: Study Protocol

BfArM AWB Datenbank

View Document

Other Identifiers

DAL-REG01-GER

Identifier Type: -

Identifier Source: org_study_id