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

NCT06089044 | Completed

• 1 other identifier: CHT/URC/2023/12
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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. Translated with www.DeepL.com/Translator (free version)

Conditions

Prosthesis-related Infections

Outcome Measures

Primary Outcomes (1)

• efficacy of suppressive Dalbavancin therapy

  Proportion of patients successfully treated with Dalbavancin. The efficacy of suppressive therapy will be defined over a two-year period after initiation of treatment as the combination of the following criteria: Clinical control of infection : * Absence of local inflammatory signs (erythema, discharge, edema, pain) ; * Absence of general signs (hyperthermia: T°\>38 or hypothermia T°\< 36°); Biological control: o CRP negative (\<5mg/l) ;

  two-year follow-up after initiation of suppressive therapy with Dalbavancin

Interventions

Dalbavancin Injection DRUG

Dalbavancin as long-term suppressive therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for a prosthetic device infection requiring suppressive antibiotic therapy for more than 6 months.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tourcoing Hospital: lead

Study Sites (1)

CH Tourcoing

Tourcoing, France

Location

MeSH Terms

Conditions

Prosthesis-Related Infections

Interventions

dalbavancin

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)