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Bacterial InfectionsNCT03696901

Xydalba Utilization Registry in Germany

An observational study of Bacterial Infections, run by Correvio International Sarl at 7 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bacterial Infections
What is being tested?
Xydalba
Type of treatment
Injection or infusion
How many people
16 participants
Where
7 sitesGermany
Study dates
21 Nov 2018to 7 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Universitätsklinikum Essen / Klinik für Infektiologie

    Essen

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen

  • Martin-Luther-Universität Halle-Wittenberg

    Halle

  • Universitätsklinikum Jena

    Jena

  • Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene

    München

  • Universitätsklinikum Regensburg /Stabsstelle Infektiologie

    Regensburg

  • Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin

    Rostock

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Xydalba
Keywords
Dalbavancine, Xydalba
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XydalbaDrug

    Also called Dalbavancin

    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 groups in NCT03696901
Study groupRoleWhat they receive
use of Xydalba, >18 yearsMale and female patients, ≥18 years of age at the time of receipt of Xydalba. Patients who received at least one Xydalba administration in Germany
Receives: Drug: Xydalba

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day of first dose

Secondary outcomes (4)

  1. Clinical response

    Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)

    Measured: at 30 days after first dose

  2. Clinical response by diagnosis

    Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)

    Measured: at 30 days after first dose

  3. Time from Xydalba treatment onset to clinical response

    Measured: up to 30 days after first dose

  4. Adverse Events, Adverse Drug Reactions and Special Situations

    Measured: up to 30 days after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start21 Nov 2018
  3. Primary completion30 Mar 2020
  4. Study completion7 Apr 2020

Why it stopped: Terminated

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696901
Sponsor's protocol ID
DAL-REG01-GER
Status last verified
Jul 2020
First submitted
9 May 2018
Last updated
17 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 25859123

  • 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.

    PubMed 23663184

  • 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.

    PubMed 27021418

  • 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.

    PubMed 26341488

  • 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.

    PubMed 24897082

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

Questions about this trial

What is this clinical trial studying?

An observational study of Bacterial Infections, run by Correvio International Sarl at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Terminated). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696901, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.

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