Xydalba Utilization Registry in Germany

Correvio Pharma

Status: Terminated

Conditions: Bacterial Infections

Treatments: Drug: Xydalba

Study type: Observational

Funder types: Industry

Identifiers

NCT03696901

DAL-REG01-GER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

16 participants in 1 patient group

use of Xydalba, >18 years

Description:

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

Treatment:

Drug: Xydalba