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

Prosthesis-related Infections Clinical Trial

— DALBASAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089044
• Other study ID #: CHT/URC/2023/12
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Tourcoing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Prosthesis-related Infections

Intervention

Drug:
• Dalbavancin Injection
Dalbavancin as long-term suppressive therapy.

Locations

Country	Name	City	State
France	CH Tourcoing	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
Tourcoing Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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