Xydalba Utilization Registry in Germany

Bacterial Infections Clinical Trial

Official title:

Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03696901
• Other study ID #: DAL-REG01-GER
• Status: Terminated
• Start date: November 21, 2018
• Est. completion date: April 7, 2020

Study information

• Verified date: July 2020
• Source: Correvio International Sarl
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: April 7, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Essen / Klinik für Infektiologie	Essen
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	Martin-Luther-Universität Halle-Wittenberg	Halle/Saale
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

Sponsors (3)

Lead Sponsor	Collaborator
Correvio International Sarl	AMS Advanced Medical Services GmbH, PrimeVigilance

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

EMA Assessment Report 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002840/WC500183871.pdf

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. — View Citation

Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products

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

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. Review. — View Citation

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. — View Citation

Ventola CL. The antibiotic resistance crisis: part 1: causes and threats. P T. 2015 Apr;40(4):277-83. — View Citation

Xydalba approval history. Drugs.com. http://www.drugs.com/history/Xydalba.html. Accessed February 3, 2016

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Xydalba Treatment dose(s)	Dose(s) of Xydalba in mg per infusion	up to 30 days after first dose
Other	Number of Xydalba Infusions	number of Infusions given	up to 30 days after first dose
Other	Length of Xydalba Infusions	length of Infusions in minutes	up to 30 days after first dose
Other	Days of Xydalba treatment	number of Days of treatment	up to 30 days after first dose
Other	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
Other	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
Other	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)
Other	Reason for discontinuation	descriptive listing of type of reasons	up to 30 days after first dose
Primary	Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis		Day of first dose
Secondary	Clinical response	Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)	at 30 days after first dose
Secondary	Clinical response by diagnosis	Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)	at 30 days after first dose
Secondary	Time from Xydalba treatment onset to clinical response		up to 30 days after first dose
Secondary	Adverse Events, Adverse Drug Reactions and Special Situations		up to 30 days after first dose

External Links

•   European Medicines Agency