Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-05 @ 5:17 AM
Study NCT ID:
NCT03611634
Status:
UNKNOWN
Last Update Posted:
2021-08-30
First Post:
2018-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE', 'timeFrame': '36 months', 'description': 'The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut microbiote, bone and joint infection, antibiotics'], 'conditions': ['Bone and Joint Infection']}, 'descriptionModule': {'briefSummary': 'Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection \\[PJI\\]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.\n\nHowever, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.\n\nThe aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital\n* Patients not opposed to participate to the study\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03611634', 'briefTitle': 'Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine', 'orgStudyIdInfo': {'id': '18-126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE', 'description': 'The aim of this study is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.', 'interventionNames': ['Other: BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE']}], 'interventions': [{'name': 'BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE', 'type': 'OTHER', 'description': 'collection of saddles', 'armGroupLabels': ['BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eugenie Mabrut, CRA', 'role': 'CONTACT'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Eugenie mabrut', 'role': 'CONTACT', 'email': 'eugenie.mabrut@chu-lyon.fr', 'phone': '04 26 73 29 38'}], 'overallOfficials': [{'name': 'Tristan Ferry, Md,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon - Hopital de la Croix Rousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Assistant', 'investigatorFullName': 'Eugénie MABRUT', 'investigatorAffiliation': 'Hospices Civils de Lyon'}}}}