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| Name | Class |
|---|---|
| AMS Advanced Medical Services GmbH | INDUSTRY |
| PrimeVigilance | INDUSTRY |
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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.
OBJECTIVES
The objectives of this registry are as follows:
To determine the following characteristics in patients who received intravenous Xydalba administration:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Germany |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis | Day of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable) | at 30 days after first dose |
| Clinical response by diagnosis | Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis) |
| Measure | Description | Time Frame |
|---|---|---|
| Xydalba Treatment dose(s) | Dose(s) of Xydalba in mg per infusion | up to 30 days after first dose |
| Number of Xydalba Infusions | number of Infusions given |
Inclusion Criteria A patient must meet all of the following criteria to be eligible for participation in the study.
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.
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The registry will capture the data in real world setting on patients who received at least one does of Xydalba.
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| Name | Affiliation | Role |
|---|---|---|
| Kiran Bhirangi, MBBS FRCS I | Correvio International Sarl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Essen / Klinik für Infektiologie | Essen | Germany | ||||
| Universitätsklinikum Gießen und Marburg GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25859123 | Background | Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83. | |
| 23663184 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Xydalba | Study Protocol | View IPD |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 5, 2021 | |
| Reset | Aug 31, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 5, 2021 | Aug 31, 2021 |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C469289 | dalbavancin |
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|
|
| at 30 days after first dose |
| Time from Xydalba treatment onset to clinical response | up to 30 days after first dose |
| Adverse Events, Adverse Drug Reactions and Special Situations | up to 30 days after first dose |
| up to 30 days after first dose |
| Length of Xydalba Infusions | length of Infusions in minutes | up to 30 days after first dose |
| Days of Xydalba treatment | number of Days of treatment | up to 30 days after first dose |
| Percentage of monotherapy vs. concurrent therapy | % of cases for which Xydalba is given as monotherapy and % of cases for which Xydalba is given as concurrent therapy | up to 30 days after first dose |
| Percentage first-line vs. subsequent-line monotherapy | % of cases for which Xydalba is given as first-line and % of cases for which Xydalba is given as subsequent-line | up to 30 days after first dose |
| Prior Antibiotic Therapies | Descriptive summary of other antibiotic therapies received | from the time of the primary specified infectious disease diagnosis until Xydalba treatment (estimated to be within 3 months of Xydalba treatment) |
| Reason for discontinuation | descriptive listing of type of reasons | up to 30 days after first dose |
| Giessen |
| Germany |
| Martin-Luther-Universität Halle-Wittenberg | Halle | Germany |
| Universitätsklinikum Jena | Jena | Germany |
| Klinikum der Universität München / Klinische Mikrobiologie und Krankenhaushygiene | München | Germany |
| Universitätsklinikum Regensburg /Stabsstelle Infektiologie | Regensburg | Germany |
| Universitätsklinikum Rostock Abteilung für Tropenmedizin und Infektionskrankheiten Zentrum für Innere Medizin | Rostock | Germany |
| Background | 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 |
| 27021418 | Background | 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. |
| Background | EMA Assessment Report 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002840/WC500183871.pdf |
| 26341488 | Background | 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. |
| Background | Xydalba approval history. Drugs.com. http://www.drugs.com/history/Xydalba.html. Accessed February 3, 2016 |
| 24897082 | Background | 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. |
| Background | Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products |
BfArM AWB Datenbank |