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NCT Number: NCT03726216

Xydalba Utilization Registry in France

This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in France. 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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales, Ajaccio, France

Loading trial locations.

About this study

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 registry of adult patients treated with Xydalba in France.

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 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patient associate to a social protection scheme, ≥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

Exclusion criteria

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

Treatment and study plan

Xydalba

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

Other names: Dalbavancine

Primary outcomes

  1. Clinical response

    Time frame: 30 days

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

Secondary outcomes

  1. Clinical response by diagnosis

    Time frame: 30 days

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

  2. Clinical response by diagnosis

    Time frame: 30 days

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

  3. Time from Xydalba treatment onset to clinical response

    Time frame: 30 days

  4. Adverse Events, Adverse Drug Reactions and Special Situations

    Time frame: 30 days

Other outcomes

  1. Xydalba Treatment dose(s)

    Time frame: 30 days

    Dose(s) of Xydalba in mg per infusion

  2. Number of Xydalba Infusions

    Time frame: 30 days

    number of Infusions given

  3. Length of Xydalba Infusions

    Time frame: 30 days

    length of Infusions in minutes

  4. Days of Xydalba treatment

    Time frame: 30 days

    number of Days of treatment

  5. Percentage of monotherapy vs. concurrent therapy

    Time frame: 30 days

    % 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: 30 days

    % 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: 30 days

    Descriptive summary of other antibiotic therapies received

  8. Reason for discontinuation

    Time frame: 30 days

    descriptive listing of type of reasons

Sponsors and collaborators

Lead sponsor

Correvio International Sarl

Industry

Collaborators

  • PrimeVigilance
  • Universal Medical Group

Registry information

Official study title

Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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