Clinical trial NCT02378493: Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
Official title: Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Staphylococcus Aureus
Keywords: Antibiogramme
Antibiofilmogramme
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: BioFilm Control
First posted: 2015-03-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of S. aureus strains in the wound
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: Antibiofilmogramme results
timeFrame: Baseline (Day 0)
measure: Antibiogram results
timeFrame: Baseline (Day 0)
Secondary outcomes:
measure: Presence/absence of S. aureus strains in the wound
timeFrame: Baseline
measure: Presence/absence of S. aureus strains in the wound
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: Antibiofilmogramme results
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: Antibiofilmogramme results
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: Antibiogram results
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: Antibiogram results
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: Wound surface area (mm^2)
timeFrame: Baseline (Day 0)
measure: Wound surface area (mm^2)
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: Wound surface area (mm^2)
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: Wound depth (mm)
timeFrame: Baseline (Day 0)
measure: Wound depth (mm)
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: Wound depth (mm)
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: The surface area of the wound has decreased by 40% compared to initial size: yes/no.
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: The number of bacterial strains detected in the wound.
timeFrame: Baseline (Day 0)
measure: The number of bacterial strains detected in the wound.
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: The number of bacterial strains detected in the wound.
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
timeFrame: Baseline (Day 0)
measure: The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
timeFrame: At the end of 1st antibiotics (expected average of 21 days)
measure: The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
Other outcomes:
measure: Age (years)
timeFrame: Baseline (Day 0)
measure: Sex (m/f)
timeFrame: Baseline (Day 0)
measure: Body mass index (kg/m^2)
timeFrame: Baseline (Day 0)
measure: Antiobiotics taken
timeFrame: During the treatment period (expected average of 21 days)
measure: % glycated hemoglobin
timeFrame: 30 days after end of 1st antibiotics (expected average of 51 days)
measure: Systolic pressure index at the toe (ratio)
timeFrame: Baseline (Day 0)
measure: Perception threshold for vibrations at the ankle (Hz)
timeFrame: Baseline (Day 0)
Locations:
city: Clermont Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied
city: Lyon Cedex 4
country: France
facility: CHU de Lyon - Hôpital de la Croix-Rousse
city: Nantes
country: France
facility: CHU
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
city: Pierre Benite
country: France
facility: CHU de Lyon - Centre Hospitalier Lyon Sud
city: Strasbourg Cedex
country: France
facility: CHRU de Strasbourg - Hôpital Civil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Albert Sotto, MD, PhD
role: STUDY_DIRECTOR
References: