Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 5:37 AM
Study NCT ID:
NCT04048304
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-24', 'size': 202815, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-01T11:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission of infection at 12 months after treatment', 'timeFrame': '12 months after treatment', 'description': 'no clinical and microbiological recurrences'}], 'secondaryOutcomes': [{'measure': 'costs', 'timeFrame': 'up to 12 months', 'description': 'total costs for treatment of infection'}, {'measure': 'duration of sick leave', 'timeFrame': 'up to 12 months', 'description': 'duration of sick leave for treatment of infection'}, {'measure': 'length of hospital stay', 'timeFrame': 'up to 12 months', 'description': 'number of days of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '32028985', 'type': 'DERIVED', 'citation': 'Betz M, Uckay I, Schupbach R, Grober T, Botter SM, Burkhard J, Holy D, Achermann Y, Farshad M. Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials). Trials. 2020 Feb 6;21(1):144. doi: 10.1186/s13063-020-4047-3.'}]}, 'descriptionModule': {'briefSummary': 'We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between\n\n1. Six and twelve weeks of antibiotic therapy if there is an implant left in place\n2. Three and six weeks of antibiotic therapy if there is no implant left'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spine surgery and intraoperative debridement with any technique\n* At least 12 months of scheduled follow-up from hospitalization\n* Bacterial spine infection of any nature, independently of implants or co-morbidities\n\nExclusion Criteria:\n\n* Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine\n* Non-resected cancer in the infection site\n* Bone marrow or recent solid organ transplant patient (Recent: \\<5 years)\n* Any other infection in the patient requiring more than 6 weeks of antibiotic therapy\n* More than three intraoperative debridements performed for spine infection\n* Absence of at least one surgical intraoperative debridement of infection'}, 'identificationModule': {'nctId': 'NCT04048304', 'briefTitle': 'Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'SASI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'short antibiotic therapy', 'description': '3 weeks of antibiotic therapy with no implant left in place 6 weeks of antibiotic therapy with implant left in place', 'interventionNames': ['Drug: duration of standard antibiotic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'long antibiotic therapy', 'description': '6 weeks of antibiotic therapy with no implant in place 12 weeks of antibiotic therapy with implant left in place', 'interventionNames': ['Drug: duration of standard antibiotic therapy']}], 'interventions': [{'name': 'duration of standard antibiotic therapy', 'type': 'DRUG', 'otherNames': ['Co-amoxiclav, vancomycin'], 'description': "antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight.", 'armGroupLabels': ['long antibiotic therapy', 'short antibiotic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Ilker Uckay, MD', 'role': 'CONTACT', 'email': 'ilker.uckay@balgrist.ch', 'phone': '+41 44 386 37 05'}, {'name': 'Regula Schupbach', 'role': 'CONTACT', 'email': 'regula.schuepbach@balgrist.ch', 'phone': '+41 44 510 73 75'}], 'facility': 'Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Ilker Uckay, PD Dr med', 'role': 'CONTACT', 'email': 'ilker.uckay@balgrist.ch', 'phone': '+41 44 386 1111'}, {'name': 'Michael Betz, PD Dr med', 'role': 'CONTACT', 'email': 'michael.betz@balgrist.ch', 'phone': '+41 44 386 1111'}], 'overallOfficials': [{'name': 'Ilker Uckay, PD Dr med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Balgrist University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'identifying IPD will not be shared with other Researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}