NCT03696901

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2020

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

May 9, 2018

Last Update Submit

July 15, 2020

Conditions

Bacterial Infections

Keywords

DalbavancineXydalba

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis

    Day of first dose

Secondary Outcomes (4)

  • Clinical response

    at 30 days after first dose

  • Clinical response by 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 Outcomes (8)

  • Xydalba Treatment dose(s)

    up to 30 days after first dose

  • Number of Xydalba Infusions

    up to 30 days after first dose

  • Length of Xydalba Infusions

    up to 30 days after first dose

  • +5 more other outcomes

Study Arms (1)

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

Interventions

XydalbaDRUG

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

Also known as: Dalbavancin
use of Xydalba, >18 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Male and female patient, ≥18 years of age at the time of receipt of Xydalba.
  • The patient received at least one infusion of Xydalba.
  • Patient signed the consent form

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universitätsklinikum Essen / Klinik für Infektiologie

Essen, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene

München, Germany

Location

Universitätsklinikum Regensburg /Stabsstelle Infektiologie

Regensburg, Germany

Location

Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin

Rostock, Germany

Location

Related Publications (9)

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

    PMID: 25859123BACKGROUND

  • 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.

    PMID: 23663184BACKGROUND

  • 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

    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.

    PMID: 27021418BACKGROUND

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

    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.

    PMID: 26341488BACKGROUND

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

    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.

    PMID: 24897082BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Kiran Bhirangi, MBBS FRCS I

    Correvio International Sarl

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

October 5, 2018

Study Start

November 21, 2018

Primary Completion

March 30, 2020

Study Completion

April 7, 2020

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (Xydalba)Access

Locations

DE(7)