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

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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Key information

Conditions

Prosthesis-Related Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Tourcoing

Tourcoing, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dalbavancin Injection

Drug

Dalbavancin as long-term suppressive therapy.

Primary outcomes

efficacy of suppressive Dalbavancin therapy

Time frame: 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) ;

Sponsors and collaborators

Lead sponsor

Tourcoing Hospital

Other

Registry information

Acronym: DALBASAT

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 18, 2023
Registry last updated: Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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