Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
- Conditions
- Prosthesis-related Infections
- Registration Number
- NCT06089044
- Lead Sponsor
- Tourcoing Hospital
- 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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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
- Patients requiring suppressive antibiotic therapy (>6 months) with dalbavancin.
- Patients who are protected adult;
- Patients who are minors;
- Patients having expressed their opposition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of suppressive Dalbavancin therapy two-year follow-up after initiation of suppressive therapy with Dalbavancin 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) ;
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CH Tourcoing
🇫🇷Tourcoing, France