Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections (BioFilm PieDia)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Staphylococcus Aureus
• Intervention / Treatment: Biological: Antibiofilmogramme

Detailed Description

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
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied
  • Lyon, France, 69317
    • CHU de Lyon - Hôpital de la Croix-Rousse
  • Nantes, France
    • CHU
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Pierre-Bénite, France, 69310
    • CHU de Lyon - Centre Hospitalier Lyon Sud
  • Strasbourg, France, 67091
    • CHRU de Strasbourg - Hôpital Civil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure: Concordance between tests; The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients whose antibiogrammes and Antibiofilmogrammes are concordant will fall into this group (the "exposed" group). Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed.	Biological: Antibiofilmogramme; An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
Experimental: Non exposure: Not concordance between tests.; The study population is composed of diabetic patients with foot wounds (at least stage >=2) that are infected by at least 1 strain of S. aureus. Patients who do not fall into the concordance (exposure) group, will fall into the non exposure group. The latter includes semi-concordance or discordance between antibiogrammes and Antiobiofilmogrammes. Upon inclusion, 1) all patients' wounds will be sampled, and 2) the associated bacterial strains identified via Vitek and 3) antibiograms performed; the latter are all part of routine procedure. 4) S. aureus isolates will be further analysed via an antiobiofilmogramme, which is an experimental element added by this research. At the end of the 1st regimen of antibiotics prescribed, if the treatment failed steps 1 to 4 can be repeated. 30 days after the end of the 1st regimen of antibiotics prescribed, steps 1 to 4 are systematically performed.	Biological: Antibiofilmogramme; An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of S. aureus strains in the wound		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.	Baseline (Day 0)
Antibiogram results	Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.	Baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of S. aureus strains in the wound		Baseline
Presence/absence of S. aureus strains in the wound		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.	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.	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.	At the end of 1st antibiotics (expected average of 21 days)
Antibiogram results	Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.	30 days after end of 1st antibiotics (expected average of 51 days)
Wound surface area (mm^2)		Baseline (Day 0)
Wound surface area (mm^2)		At the end of 1st antibiotics (expected average of 21 days)
Wound surface area (mm^2)		30 days after end of 1st antibiotics (expected average of 51 days)
Wound depth (mm)		Baseline (Day 0)
Wound depth (mm)		At the end of 1st antibiotics (expected average of 21 days)
Wound depth (mm)		30 days after end of 1st antibiotics (expected average of 51 days)
The surface area of the wound has decreased by 40% compared to initial size: yes/no.		30 days after end of 1st antibiotics (expected average of 51 days)
The number of bacterial strains detected in the wound.		Baseline (Day 0)
The number of bacterial strains detected in the wound.		At the end of 1st antibiotics (expected average of 21 days)
The number of bacterial strains detected in the wound.		30 days after end of 1st antibiotics (expected average of 51 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics	Score varying from 0 to 80	Baseline (Day 0)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics	Score varying from 0 to 80	At the end of 1st antibiotics (expected average of 21 days)
The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics	Score varying from 0 to 80	30 days after end of 1st antibiotics (expected average of 51 days)

Other Outcome Measures

Outcome Measure	Time Frame
Age (years)	Baseline (Day 0)
Sex (m/f)	Baseline (Day 0)
Body mass index (kg/m^2)	Baseline (Day 0)
Antiobiotics taken	During the treatment period (expected average of 21 days)
% glycated hemoglobin	30 days after end of 1st antibiotics (expected average of 51 days)
Systolic pressure index at the toe (ratio)	Baseline (Day 0)
Perception threshold for vibrations at the ankle (Hz)	Baseline (Day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: BioFilm Control
• Investigators: Study Director: Albert Sotto, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Dunyach-Remy C, Ngba Essebe C, Sotto A, Lavigne JP. Staphylococcus aureus Toxins and Diabetic Foot Ulcers: Role in Pathogenesis and Interest in Diagnosis. Toxins (Basel). 2016 Jul 7;8(7):209. doi: 10.3390/toxins8070209.
• Sotto A, Laurent F, Schuldiner S, Vouillarmet J, Corvec S, Bemer P, Boutoille D, Dunyach-Remy C, Lavigne JP. Evaluation of the Use of Antibiofilmogram Technology in the Clinical Evolution of Foot Ulcers Infected by Staphylococcus aureus in Persons Living with Diabetes: A Pilot Study. J Clin Med. 2021 Dec 17;10(24):5928. doi: 10.3390/jcm10245928.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2015
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimated): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Antibiogramme; Antibiofilmogramme
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Staphylococcal Infections; Diabetic Foot
• Other Study ID Numbers: LOCAL/2014/AS-01b; 2014-A01745-42 (Other Identifier: ANSM)