Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

Centre Hospitalier Universitaire de Nīmes33 enrolled

Overview

This is an observational study that does not change routine care. The primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in the presence/absence of S. aureus strains at the end of a first regimen of antibiotics.

The secondary objectives are: A. Should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms. B. To investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in wound healing. C. To study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes. D. Create an S. aureus strain collection for future ancillary studies.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

Conditions

Diabetic Foot Staphylococcus Aureus

Interventions

AntibiofilmogrammeBIOLOGICAL

An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 7 to 10 weeks of follow-up * Patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of S. aureus Exclusion Criteria: * The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * Emergency situation precluding correct study implementation

Locations (6)

CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, France

CHU de Lyon - Hôpital de la Croix-Rousse

Lyon, France

CHU

Nantes, France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, France

Outcomes

Primary Outcomes

Presence/absence of S. aureus strains in the wound

Time frame: At the end of 1st antibiotics (expected average of 21 days)

Antibiofilmogramme results

Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

Time frame: Baseline (Day 0)

Antibiogram results

Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

Time frame: Baseline (Day 0)

Secondary Outcomes

Presence/absence of S. aureus strains in the wound

Time frame: Baseline

Presence/absence of S. aureus strains in the wound

Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)

Antibiofilmogramme results

Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

Time frame: At the end of 1st antibiotics (expected average of 21 days)

Antibiofilmogramme results

Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

Time frame: 30 days after end of 1st antibiotics (expected average of 51 days)

Antibiogram results

Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

Time frame: At the end of 1st antibiotics (expected average of 21 days)

Data from ClinicalTrials.gov

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