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Xydalba Utilization Registry in France

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ClinicalTrials.gov Identifier: NCT03726216
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Universal Medical Group
PrimeVigilance
Information provided by (Responsible Party):
Correvio International Sarl

Brief Summary:

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.


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 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France
Actual Study Start Date : September 6, 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 France
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: Dalbavancine




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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
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:

  • 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.

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): NCT03726216


Contacts
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Contact: Nathalie Dunkel, MSc +41 (0) 22 907 79 67 ndunkel@correvio.com

Locations
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France
Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales Not yet recruiting
Ajaccio, France
Contact: Bernard Castan, MD         
Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André Active, not recruiting
Bordeaux, France
CHU Bordeaux Pellegrin Active, not recruiting
Bordeaux, France
Hôpital Raymond-Poincaré Active, not recruiting
Garches, France
CHU GRENOBLE, Maladies infectieuses et tropicales Recruiting
Grenoble, France
Contact: Jean-Paul STAHL, MD         
Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales Active, not recruiting
Lyon, France
Centre Hospitalier de Mont de Marsan Recruiting
Mont-de-Marsan, France
Contact: Gabriela Illes, MD         
Centre hospitalier régional et universitaire de Nancy Not yet recruiting
Nancy, France
Contact: François Goehringer, MD         
CHU de Nantes Not yet recruiting
Nantes, France
Contact: Davide Boutoille, MD         
Centre hospitalier universitaire de Nice Active, not recruiting
Nice, France
Centre Hospitalier Universitaire de Nîmes (CHU) Recruiting
Nîmes, France
Contact: Catherine Lechiche, MD         
Hôpital Ambroise-Paré,Maladies infectieuses Active, not recruiting
Paris, France
Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit Recruiting
Rennes, France
Contact: Pierre Tattevin, MD, PhD         
Centre hospitalier universitaire de Saint-Étienne Active, not recruiting
Saint-Étienne, France
Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur Recruiting
Tourcoing, France
Contact: Eric Senneville, MD         
Sponsors and Collaborators
Correvio International Sarl
Universal Medical Group
PrimeVigilance

Additional Information:

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Responsible Party: Correvio International Sarl
ClinicalTrials.gov Identifier: NCT03726216     History of Changes
Other Study ID Numbers: DAL-REG01-FRA
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bacterial Infections
Dalbavancin
Teicoplanin
Anti-Bacterial Agents
Anti-Infective Agents