Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

NCT ID: NCT06089044

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-12-31

Brief Summary

The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:

What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.

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Conditions

Prosthesis-related Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Dalbavancin Injection

Dalbavancin as long-term suppressive therapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
• Patients requiring suppressive antibiotic therapy (>6 months) with dalbavancin.

Exclusion Criteria

• Patients who are protected adult;
• Patients who are minors;
• Patients having expressed their opposition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tourcoing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Tourcoing

Tourcoing, , France

Countries

France

Other Identifiers

CHT/URC/2023/12

Identifier Type: -

Identifier Source: org_study_id