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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
Sponsor:
Collaborators:
AMS Advanced Medical Services GmbH
PrimeVigilance
Information provided by (Responsible Party):
Cardiome Pharma ( Correvio )

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.


Condition or disease Intervention/treatment
Bacterial Infections 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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Dalbavancin

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 Name: Dalbavancin




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: at 30 days after first dose ]
    Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)

  2. Clinical response by diagnosis [ Time Frame: at 30 days after first dose ]
    Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)

  3. Time from Xydalba treatment onset to clinical response [ Time Frame: up to 30 days after first dose ]
  4. Adverse Events, Adverse Drug Reactions and Special Situations [ Time Frame: up to 30 days after first dose ]

Other Outcome Measures:
  1. Xydalba Treatment dose(s) [ Time Frame: up to 30 days after first dose ]
    Dose(s) of Xydalba in mg per infusion

  2. Number of Xydalba Infusions [ Time Frame: up to 30 days after first dose ]
    number of Infusions given

  3. Length of Xydalba Infusions [ Time Frame: up to 30 days after first dose ]
    length of Infusions in minutes

  4. Days of Xydalba treatment [ Time Frame: up to 30 days after first dose ]
    number of Days of treatment

  5. 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

  6. 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

  7. 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

  8. Reason for discontinuation [ Time Frame: up to 30 days after first dose ]
    descriptive listing of type of reasons



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

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


Contacts
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Contact: Shanti Amann, Dr rer nat 0049 621 700 95 100 info@ams-europe.com
Contact: Nathalie Dunkel +41 (0) 22 907 79 67 info@correvio.com

Locations
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Germany
Universitätsklinikum Essen / Klinik für Infektiologie Not yet recruiting
Essen, Germany
Contact: Sebastian Dolff, PD Dr. med.         
Universitätsklinikum Leipzig / Institut für Medizinische Mikrobiologie und Infektionsepidemiologie Not yet recruiting
Leipzig, Germany
Contact: Arne C Rodloff, Prof Dr med.         
Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene Not yet recruiting
München, Germany
Contact: Beatrice Grabein, Dr. med.         
Universitätsklinikum Regensburg /Stabsstelle Infektiologie Not yet recruiting
Regensburg, Germany
Contact: Frank Hanses, PD Dr. med.         
Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin Not yet recruiting
Rostock, Germany
Contact: Micha Löbermann, PD Dr. med.         
Sponsors and Collaborators
Correvio
AMS Advanced Medical Services GmbH
PrimeVigilance
Investigators
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Study Director: Kiran Bhirangi, MBBS FRCS I Correvio

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Xydalba
BfArM AWB Datenbank

Publications:
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
EMA Assessment Report 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002840/WC500183871.pdf
Xydalba approval history. Drugs.com. http://www.drugs.com/history/Xydalba.html. Accessed February 3, 2016
Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products

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Responsible Party: Correvio
ClinicalTrials.gov Identifier: NCT03696901     History of Changes
Other Study ID Numbers: DAL-REG01-GER
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Cardiome Pharma ( Correvio ):
Dalbavancine
Xydalba

Additional relevant MeSH terms:
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Bacterial Infections
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents