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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Diabetic Foot; Staphylococcus Aureus

Treatments: Biological: Antibiofilmogramme

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02378493

2014-A01745-42 (Other Identifier)

LOCAL/2014/AS-01b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Exposure: Concordance between tests

Experimental group

Description:

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.

Treatment:

Biological: Antibiofilmogramme

Non exposure: Not concordance between tests.

Experimental group

Description:

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.

Treatment:

Biological: Antibiofilmogramme