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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06089044
Acronym
DALBASAT
Enrollment
15
Registered
2023-10-18
Start date
2020-01-01
Completion date
2022-12-31
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthesis-related Infections

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)

Interventions

DRUGDalbavancin Injection

Dalbavancin as long-term suppressive therapy.

Sponsors

Tourcoing Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
efficacy of suppressive Dalbavancin therapytwo-year follow-up after initiation of suppressive therapy with DalbavancinProportion 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) ;

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026