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

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ClinicalTrials.gov Identifier: NCT02378493
Recruitment Status : Recruiting
First Posted : March 4, 2015
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
BioFilm Control
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.


Condition or disease Intervention/treatment
Diabetic Foot Staphylococcus Aureus Biological: Antibiofilmogramme

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.


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
Actual Study Start Date : December 16, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. Presence/absence of S. aureus strains in the wound [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
  2. Antibiofilmogramme results [ Time Frame: Baseline (Day 0) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

  3. Antibiogram results [ Time Frame: Baseline (Day 0) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.


Secondary Outcome Measures :
  1. Presence/absence of S. aureus strains in the wound [ Time Frame: Baseline ]
  2. Presence/absence of S. aureus strains in the wound [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  3. Antibiofilmogramme results [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

  4. Antibiofilmogramme results [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

  5. Antibiogram results [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

  6. Antibiogram results [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
    Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.

  7. Wound surface area (mm^2) [ Time Frame: Baseline (Day 0) ]
  8. Wound surface area (mm^2) [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
  9. Wound surface area (mm^2) [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  10. Wound depth (mm) [ Time Frame: Baseline (Day 0) ]
  11. Wound depth (mm) [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
  12. Wound depth (mm) [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  13. The surface area of the wound has decreased by 40% compared to initial size: yes/no. [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  14. The number of bacterial strains detected in the wound. [ Time Frame: Baseline (Day 0) ]
  15. The number of bacterial strains detected in the wound. [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
  16. The number of bacterial strains detected in the wound. [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  17. The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics [ Time Frame: Baseline (Day 0) ]
    Score varying from 0 to 80

  18. The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics [ Time Frame: At the end of 1st antibiotics (expected average of 21 days) ]
    Score varying from 0 to 80

  19. The capacity of the S. aureus strains isolated to create biofilms in the presence of antibiotics [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
    Score varying from 0 to 80


Other Outcome Measures:
  1. Age (years) [ Time Frame: Baseline (Day 0) ]
  2. Sex (m/f) [ Time Frame: Baseline (Day 0) ]
  3. Body mass index (kg/m^2) [ Time Frame: Baseline (Day 0) ]
  4. Antiobiotics taken [ Time Frame: During the treatment period (expected average of 21 days) ]
  5. % glycated hemoglobin [ Time Frame: 30 days after end of 1st antibiotics (expected average of 51 days) ]
  6. Systolic pressure index at the toe (ratio) [ Time Frame: Baseline (Day 0) ]
  7. Perception threshold for vibrations at the ankle (Hz) [ Time Frame: Baseline (Day 0) ]

Biospecimen Retention:   Samples Without DNA
The S aureus strains encountered will be maintained in a collection for future ancillary studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378493


Contacts
Contact: Albert Sotto, MD, PhD +33.(0)4.66.68.41.49 albert.sotto@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied Not yet recruiting
Clermont Ferrand, France, 63003
Principal Investigator: Richard Bonnet, MD, PhD         
Sub-Investigator: Olivier Lesens, MD, PhD         
CHU de Lyon - Hôpital de la Croix-Rousse Recruiting
Lyon Cedex 4, France, 69317
Sub-Investigator: Frédéric Laurent, MD         
Sub-Investigator: Jean Philippe Rasigade, MD         
CHU Not yet recruiting
Nantes, France
Contact: David BOUTOILLE         
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Jean Philippe Lavigne, MD, PhD         
Sub-Investigator: Albert Sotto, MD, PhD         
CHU de Lyon - Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Sub-Investigator: Gérad Lina, MD, PhD         
Sub-Investigator: Julien Vouillarmet, MD         
Sub-Investigator: Paul Michon, MD         
CHRU de Strasbourg - Hôpital Civil Not yet recruiting
Strasbourg Cedex, France, 67091
Principal Investigator: Laurence Kessler, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
BioFilm Control
Investigators
Study Director: Albert Sotto, MD, PhD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02378493     History of Changes
Other Study ID Numbers: LOCAL/2014/AS-01b
2014-A01745-42 ( Other Identifier: RCB number )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: June 2017

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Antibiogramme
Antibiofilmogramme

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Anti-Bacterial Agents
Anti-Infective Agents