Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

Diabetic Foot Clinical Trial

— BioFilm PieDia  

Official title:

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378493
• Other study ID #: LOCAL/2014/AS-01b
• Secondary ID: 2014-A01745-42
• Status: Completed
• Start date: December 16, 2015
• Est. completion date: July 14, 2019

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 14, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Staphylococcus Aureus

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied	Clermont Ferrand
France	CHU de Lyon - Hôpital de la Croix-Rousse	Lyon Cedex 4
France	CHU	Nantes
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09
France	CHU de Lyon - Centre Hospitalier Lyon Sud	Pierre Benite
France	CHRU de Strasbourg - Hôpital Civil	Strasbourg Cedex

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	BioFilm Control

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age (years)		Baseline (Day 0)
Other	Sex (m/f)		Baseline (Day 0)
Other	Body mass index (kg/m^2)		Baseline (Day 0)
Other	Antiobiotics taken		During the treatment period (expected average of 21 days)
Other	% glycated hemoglobin		30 days after end of 1st antibiotics (expected average of 51 days)
Other	Systolic pressure index at the toe (ratio)		Baseline (Day 0)
Other	Perception threshold for vibrations at the ankle (Hz)		Baseline (Day 0)
Primary	Presence/absence of S. aureus strains in the wound		At the end of 1st antibiotics (expected average of 21 days)
Primary	Antibiofilmogramme results	Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.	Baseline (Day 0)
Primary	Antibiogram results	Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.	Baseline (Day 0)
Secondary	Presence/absence of S. aureus strains in the wound		Baseline
Secondary	Presence/absence of S. aureus strains in the wound		30 days after end of 1st antibiotics (expected average of 51 days)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Wound surface area (mm^2)		Baseline (Day 0)
Secondary	Wound surface area (mm^2)		At the end of 1st antibiotics (expected average of 21 days)
Secondary	Wound surface area (mm^2)		30 days after end of 1st antibiotics (expected average of 51 days)
Secondary	Wound depth (mm)		Baseline (Day 0)
Secondary	Wound depth (mm)		At the end of 1st antibiotics (expected average of 21 days)
Secondary	Wound depth (mm)		30 days after end of 1st antibiotics (expected average of 51 days)
Secondary	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)
Secondary	The number of bacterial strains detected in the wound.		Baseline (Day 0)
Secondary	The number of bacterial strains detected in the wound.		At the end of 1st antibiotics (expected average of 21 days)
Secondary	The number of bacterial strains detected in the wound.		30 days after end of 1st antibiotics (expected average of 51 days)
Secondary	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)
Secondary	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)
Secondary	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)