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

• Sponsor: Tourcoing Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06089044
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 36
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Prosthesis-related Infections	Drug: Dalbavancin Injection

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Dec 31, 2022
• Actual Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. 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) ;

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Tourcoing	Tourcoing		France

Sponsors and Collaborators

• Tourcoing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tourcoing Hospital
• ClinicalTrials.gov Identifier: NCT06089044
• Other Study ID Numbers: CHT/URC/2023/12
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Prosthesis-Related Infections; Dalbavancin

Study Results

No Results Posted as of Oct 18, 2023