Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

NCT02378493 | Completed

• 2 other identifiers: LOCAL/2014/AS-01b2014-A01745-42
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Diabetic Foot; Staphylococcus Aureus

Keywords

Antibiogramme; Antibiofilmogramme

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (19)

• 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

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

• Antibiofilmogramme results

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

• Antibiogram results

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

Other Outcomes (7)

• Age (years)

  Baseline (Day 0)

• Sex (m/f)

  Baseline (Day 0)

• Body mass index (kg/m^2)

  Baseline (Day 0)

Study Arms (2)

Exposure: Concordance between tests

EXPERIMENTAL

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

Non exposure: Not concordance between tests.

EXPERIMENTAL

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

Interventions

Antibiofilmogramme BIOLOGICAL

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

Exposure: Concordance between tests; Non exposure: Not concordance between tests.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• BioFilm Control: collaborator

Study Sites (6)

CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied

Clermont-Ferrand, 63003, France

Location

CHU de Lyon - Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

CHU

Nantes, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHRU de Strasbourg - Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 27399775 RESULT

MeSH Terms

Conditions

Diabetic Foot; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Albert Sotto, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 4, 2015
• Study Start: December 16, 2015
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: December 22, 2025

Record last verified: 2020-01

Locations

FR (6)