Clinical trial NCT03696901: Xydalba Utilization Registry in Germany
Official title: Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacterial Infections
Keywords: Dalbavancine
Xydalba
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
Collaborators: name: AMS Advanced Medical Services GmbH
name: PrimeVigilance
First posted: 2018-10-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
timeFrame: Day of first dose
Secondary outcomes:
measure: Clinical response
timeFrame: at 30 days after first dose
measure: Clinical response by diagnosis
timeFrame: at 30 days after first dose
measure: Time from Xydalba treatment onset to clinical response
timeFrame: up to 30 days after first dose
measure: Adverse Events, Adverse Drug Reactions and Special Situations
timeFrame: up to 30 days after first dose
Other outcomes:
measure: Xydalba Treatment dose(s)
timeFrame: up to 30 days after first dose
measure: Number of Xydalba Infusions
timeFrame: up to 30 days after first dose
measure: Length of Xydalba Infusions
timeFrame: up to 30 days after first dose
measure: Days of Xydalba treatment
timeFrame: up to 30 days after first dose
measure: Percentage of monotherapy vs. concurrent therapy
timeFrame: up to 30 days after first dose
measure: Percentage first-line vs. subsequent-line monotherapy
timeFrame: up to 30 days after first dose
measure: Prior Antibiotic Therapies
timeFrame: from the time of the primary specified infectious disease diagnosis until Xydalba treatment (estimated to be within 3 months of Xydalba treatment)
measure: Reason for discontinuation
timeFrame: up to 30 days after first dose
Locations:
city: Essen
country: Germany
facility: Universitätsklinikum Essen / Klinik für Infektiologie
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Halle/Saale
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: München
country: Germany
facility: Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg /Stabsstelle Infektiologie
city: Rostock
country: Germany
facility: Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin
Study officials:
affiliation: Correvio International Sarl
name: Kiran Bhirangi, MBBS FRCS I
role: STUDY_DIRECTOR
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citation: Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products