Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
NCT ID: NCT02378493
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2015-12-16
2019-07-17
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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BioFilm Control
INDUSTRY
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Albert Sotto, MD, PhD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Nîmes
Locations
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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
CHU de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHRU de Strasbourg - Hôpital Civil
Strasbourg, , France
Countries
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References
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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.
Other Identifiers
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2014-A01745-42
Identifier Type: OTHER
Identifier Source: secondary_id
LOCAL/2014/AS-01b
Identifier Type: -
Identifier Source: org_study_id