Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT02378493
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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)'}], 'primaryOutcomes': [{'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)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}, {'measure': 'Antibiogram results', 'timeFrame': 'Baseline (Day 0)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}], 'secondaryOutcomes': [{'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)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}, {'measure': 'Antibiofilmogramme results', 'timeFrame': '30 days after end of 1st antibiotics (expected average of 51 days)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}, {'measure': 'Antibiogram results', 'timeFrame': 'At the end of 1st antibiotics (expected average of 21 days)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}, {'measure': 'Antibiogram results', 'timeFrame': '30 days after end of 1st antibiotics (expected average of 51 days)', 'description': 'Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance.'}, {'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)', 'description': 'Score varying from 0 to 80'}, {'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)', 'description': 'Score varying from 0 to 80'}, {'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)', 'description': 'Score varying from 0 to 80'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antibiogramme', 'Antibiofilmogramme'], 'conditions': ['Diabetic Foot', 'Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '27399775', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study that does not change routine care.\n\nThe 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.', 'detailedDescription': 'The secondary objectives are:\n\nA. Should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms.\n\nB. To investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in wound healing.\n\nC. To study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes.\n\nD. Create an S. aureus strain collection for future ancillary studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 7 to 10 weeks of follow-up\n* Patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of S. aureus\n\nExclusion Criteria:\n\n* 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\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant, parturient, or breastfeeding\n* Emergency situation precluding correct study implementation'}, 'identificationModule': {'nctId': 'NCT02378493', 'acronym': 'BioFilm PieDia', 'briefTitle': 'Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Evaluation of the Antibiofilmogramme® Test During Diabetic Foot Infections', 'orgStudyIdInfo': {'id': 'LOCAL/2014/AS-01b'}, 'secondaryIdInfos': [{'id': '2014-A01745-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exposure: Concordance between tests', 'description': '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).\n\nUpon 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.', 'interventionNames': ['Biological: Antibiofilmogramme']}, {'type': 'EXPERIMENTAL', 'label': 'Non exposure: Not concordance between tests.', 'description': "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.\n\nUpon 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.", 'interventionNames': ['Biological: Antibiofilmogramme']}], 'interventions': [{'name': 'Antibiofilmogramme', 'type': 'BIOLOGICAL', 'description': 'An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.', 'armGroupLabels': ['Exposure: Concordance between tests', 'Non exposure: Not concordance between tests.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand - Hôpital Gabriel-Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'CHU de Lyon - Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CHU de Lyon - Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHRU de Strasbourg - Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Albert Sotto, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioFilm Control', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}