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: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France, 63003
    • CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied
  • Lyon Cedex 4, France, 69317
    • CHU de Lyon - Hôpital de la Croix-Rousse
  • Nantes, France
    • CHU
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
  • Pierre Benite, France, 69310
    • CHU de Lyon - Centre Hospitalier Lyon Sud
  • Strasbourg Cedex, 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
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
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

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2015
• Primary Completion (Actual): July 14, 2019
• Study Completion (Actual): July 14, 2019

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Antibiogramme; Antibiofilmogramme
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: LOCAL/2014/AS-01b; 2014-A01745-42 (Other Identifier: RCB number)