Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-02 @ 7:51 AM
Study NCT ID:
NCT02222792
Status:
UNKNOWN
Last Update Posted:
2014-08-21
First Post:
2014-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serologic assays of sera collected from septic or non-septic patients will be performed in series and operators will be blind in terms of clinical and microbiological status in order to avoid any interpretation bias due to information collected in advance'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-20', 'studyFirstSubmitDate': '2014-08-19', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of test BJI 2', 'timeFrame': '2 years', 'description': 'The diagnostic performance of the test during unique titration.\n\n* Sensitivity: estimated from the proportion of septic group patients with an antibody level above the defined threshold antibody concentration.\n* Specificity: estimated from the proportion of non-septic-group patients with an antibody level less than or equal to the defined threshold antibody concentration.\n* Positive likelihood ratio.\n* Negative likelihood ratio.'}], 'secondaryOutcomes': [{'measure': 'Interest of test BJI 2', 'timeFrame': '2 years', 'description': '* To evaluate the diagnostic interest of the BJI Inoplex 2 test in conjunction with the clinical and laboratory data collected: diagnostic strategy and score combining several criteria.\n* To evaluate the potential medical and economic benefits of using the test: number and cost of joint aspirations or hospital stays that would have been avoided, delayed diagnosis.\n* To describe the serological outcome after surgery in septic patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staphylococci, Streptococci, P acnes and Gram-negative bacteria'], 'conditions': ['Bone and Joint Prosthetic Infections']}, 'descriptionModule': {'briefSummary': 'A national, prospective, open-label, non-interventional, multicentre, controlled study designed to evaluate a diagnostic method in patients undergoing hip, knee or shoulder prosthetic removal regardless of whether or not infection is suspected. Serological test results will have no impact on the therapeutic approach.\n\nStudy objective: To evaluate the diagnostic performance of an antibody detection kit for the serological diagnosis of bone and joint prosthetic device infections cause by Staphylococci, Streptococci, Propionibacterium acnes (P. acnes) and Gram-negative bacteria versus the reference method: the bacterial culture of deep intraoperative samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).\n\nThe non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients\n2. Patients 18 years of age or older\n3. Patient with a bone and joint prosthetic device: total hip prosthesis (THP) or total knee prosthesis (TKP) or total shoulder prosthesis (TSP)\n4. Patients with a revision of a failed prosthesis, regardless of the cause and whether septic or not\n5. Patients who have not expressed their opposition to the use of their personal medical data and blood samples\n\nExclusion Criteria:\n\n1. Patients already enrolled or clinically reviewed following a relapse\n2. Patients with several prostheses requiring at least two revisions during the same surgical procedure\n3. Patients for whom the microbiologist and/or doctor responsible for the care refuses that these patients participate in the study\n4. HIV+ patients\n5. Patients undergoing chemotherapy for a blood disease or solid tumour\n6. Patients under guardianship or trusteeship\n7. Patients who are expected to be difficult to monitor (life expectancy less than 1 year, or homeless people, foreigner in transit)'}, 'identificationModule': {'nctId': 'NCT02222792', 'briefTitle': 'BJI Inoplex 2 : Test for Diagnosis of Prosthetic Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Diaxonhit'}, 'officialTitle': 'Evaluation of the BJI Inoplex 2 Kit for the Multiplex Serological Diagnosis of Bone and Joint Prosthetic Device Infections', 'orgStudyIdInfo': {'id': 'BJI 2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Septic patient group', 'description': 'The septic patient group will be comprised of patients presenting with bone and joint prosthetic device infection confirmed by intraoperative microbiological culture (at least 2 deep positive samples for the same bacterial strain).'}, {'label': 'Non-septic patient group', 'description': 'The non-septic patient group will be comprised of prosthetic patients presenting with symptoms of mechanical loosening, and whose deep intraoperative samples have all proved negative'}, {'label': 'Intermediate group', 'description': 'An intermediate group will be comprised of patients with only one deep positive sample.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92100', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe hospitalier Diaconesses Croix Saint Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diaxonhit', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}