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Xydalba Utilization Registry in Germany

NCT03696901 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-07-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • AMS Advanced Medical Services GmbH

    collaborator INDUSTRY

  • PrimeVigilance

    collaborator INDUSTRY

  • Correvio International Sarl

    lead INDUSTRY

Principal Investigators

  • Kiran Bhirangi, MBBS FRCS I · Correvio International Sarl

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2020-03-30
Completion
2020-04-07

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03696901 on ClinicalTrials.gov