Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT03746327
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2018-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-24', 'releaseDate': '2025-11-14'}], 'estimatedResultsFirstSubmitDate': '2025-11-14'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2018-07-26', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator-assessed incidence of local signs infection at 6 months after tedizolid', 'timeFrame': '6 months', 'description': 'incidence or absence of local signs of infection at the 6 months after tedizolid treatment.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events at 12 months after ending tedizolid treatment', 'timeFrame': '12 months', 'description': 'incidence of adverse events at the 12 months after tedizolid treatment. number of Adverse Events as assessed'}, {'measure': 'Incidence of positive blood cultures during reimplantation on the two stage exchange cases.', 'timeFrame': '0, 7 days and months 1, 2, 6, 12', 'description': 'incidence blood cultures at reimplantation,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostheses Infection']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.', 'detailedDescription': 'To evaluate the efficacy of 4 weeks of 200 mg/24h of tedizolid for prosthetic join infections caused by tedizolid susceptible microorganisms treated with implant removal in one or two stages at 6 months of followup after stopping tedizolid treatment.\n\nSecondary objectives:\n\nEvaluate the efficacy of tedizolid at 12 months of follow-up; evaluate the rate of gastrointestinal adverse events with tedizolid; determine the rate of haematological abnormalities during tedizolid treatment and; in case of two-stage exchange, the rate of positive cultures during reimplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female older than 18 years who accept and sign the informed consent.\n2. Infection signs onset more than 3 months after index arthroplasty.\n3. Diagnostic of chronic (≥3 weeks of clinical symptoms) hip or knee prosthetic joint infection according to MSIS criteria \\*(Parvizi J, Gherke T. Definition of peri-prosthetic joint infection. J Arthroplasty 2014; 29: 1331)\n4. Infection due to a tedizolid susceptible microorganism.\n5. Surgical approach: one or two - stage exchange of all implant components.\n6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with a prosthetic joint infection with negative cultures.\n2. Patients who undergo debridement without removing the prosthesis or only partially removed\n3. ≥15 days of other antibiotic treatment before starting tedizolid\n4. Life expeancy ≤ 1 year.\n5. Previous enrollment in this protocol.\n6. Hypersensitivity to tedizolid or any formulation excipients.\n7. Concurrent use of another investigational medication within 30 days of study entry.\n8. Women who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03746327', 'acronym': 'PROTEDI', 'briefTitle': 'Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'English Efficacy and Tolerance of 4 Weeks of Tedizolid in Prosthetic Joint Infections Treated With Implant Removal', 'orgStudyIdInfo': {'id': 'PROTEDI 2018-002465-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sivextro arm', 'description': '200 mg milligram per day during 4 weeks', 'interventionNames': ['Drug: Sivextro 200 milligrams Oral Tablet']}], 'interventions': [{'name': 'Sivextro 200 milligrams Oral Tablet', 'type': 'DRUG', 'description': '200 mg milligram per day during 4 weeks', 'armGroupLabels': ['Sivextro arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Laura Morata', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project manager', 'investigatorFullName': 'Anna Cruceta', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-14', 'type': 'RELEASE'}, {'date': '2025-11-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Anna Cruceta, Project manager, Fundacion Clinic per a la Recerca Biomédica'}}}}