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Completed

NCT Number: NCT02378493

Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • BioFilm Control

Registry information

Acronym: BioFilm PieDia

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2015
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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