Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-10 @ 4:54 PM
Study NCT ID:
NCT06637332
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017576', 'term': 'Daptomycin'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Desirability of Outcome Ranking (DOOR)', 'timeFrame': 'Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)', 'description': 'Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined:\n\nRank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead\n\nComplications include:\n\n1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated.\n2. Infectious Complications: Including new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures; change of therapy due to inadequate clinical response.\n3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug'}], 'secondaryOutcomes': [{'measure': 'Clinical failure', 'timeFrame': 'Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)', 'description': 'Defined as the absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment.'}, {'measure': 'Serious Adverse Event or Adverse Event Leading to Discontinuation', 'timeFrame': 'Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)', 'description': 'Defined as a serious adverse drug event (Common Terminology Criteria for Adverse Events (CTCAE) class 4) presumed due to study drug OR adverse drug event (CTCAE classes 1-3) leading to discontinuation of the study drug'}, {'measure': 'All cause mortality', 'timeFrame': 'Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)', 'description': 'Death from any cause'}, {'measure': 'Infectious Complications', 'timeFrame': 'Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)', 'description': 'Defined as change in therapy for inadequate clinical response; new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures; change of antibiotic therapy due to inadequate clinical response.\n\nNew implies that the complication was not suspected at enrollment and is not a function of delay to diagnostic testing.'}, {'measure': 'Drug Induced Myostitis', 'timeFrame': 'Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)', 'description': 'Defined as a creatinine kinase level greater than or equal to 5 times the upper limit of normal'}, {'measure': 'Eosinophilic pneumonia', 'timeFrame': 'Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119)', 'description': 'Defined as the development of symptomatic eosinophilic pneumonia as diagnosed by the treating team in consultation with the appropriate specialists'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S. aureus bacteremia', 'Methicllin resistant', 'MRSA', 'S. aureus bloodstream infection', 'Daptomycin', 'Vancomycin'], 'conditions': ['Staphylococcus Aureus Septicemia', 'Staphylococcus Aureus Bacteremia', 'S. Aureus Bacteremia', 'S. Aureus Bloodstream Infection', 'Staphylococcus Aureus Endocarditis']}, 'referencesModule': {'references': [{'pmid': '37543121', 'type': 'BACKGROUND', 'citation': 'Zhang G, Zhang N, Xu J, Yang T, Yin H, Cai Y. Efficacy and safety of vancomycin for the treatment of Staphylococcus aureus bacteraemia: a systematic review and meta-analysis. Int J Antimicrob Agents. 2023 Oct;62(4):106946. doi: 10.1016/j.ijantimicag.2023.106946. Epub 2023 Aug 4.'}, {'pmid': '16914701', 'type': 'BACKGROUND', 'citation': 'Fowler VG Jr, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, Levine DP, Chambers HF, Tally FP, Vigliani GA, Cabell CH, Link AS, DeMeyer I, Filler SG, Zervos M, Cook P, Parsonnet J, Bernstein JM, Price CS, Forrest GN, Fatkenheuer G, Gareca M, Rehm SJ, Brodt HR, Tice A, Cosgrove SE; S. aureus Endocarditis and Bacteremia Study Group. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006 Aug 17;355(7):653-65. doi: 10.1056/NEJMoa053783.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label randomized controlled trial for patients with methicillin resistant S. aureus (MRSA) bloodstream infection which will directly compare the two most commonly used therapies, vancomycin and daptomycin.\n\nThis study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Methicillin-resistant S. aureus bacteremia\n\nExclusion Criteria:\n\n* Severe allergy or non-severe rash to vancomycin or daptomycin\n* Suspected or confirmed MRSA pneumonia\n* Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg/L or daptomycin MIC greater than or equal to 1mg/L'}, 'identificationModule': {'nctId': 'NCT06637332', 'acronym': 'DAPTO-SNAP', 'briefTitle': 'Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia', 'orgStudyIdInfo': {'id': '2025-10666'}, 'secondaryIdInfos': [{'id': '466322', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institutes of Health Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daptomycin', 'description': 'Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg', 'interventionNames': ['Drug: Daptomycin for Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target', 'interventionNames': ['Drug: Vancomycin (IV)']}], 'interventions': [{'name': 'Daptomycin for Injection', 'type': 'DRUG', 'description': 'Daptomycin given by injection at a dose determined by the treating team but not to be less than 6mg/kg', 'armGroupLabels': ['Daptomycin']}, {'name': 'Vancomycin (IV)', 'type': 'DRUG', 'description': 'Vancomycin by injection to be given at a dose selected by the treating team to achieve a desired trough level or AUC-based target, as determined by local standards of care', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Genevieve McKew, genevieve.mckew@health.nsw.gov', 'role': 'CONTACT', 'email': 'genevieve.mckew@health.nsw.gov.au'}, {'name': 'Genevieve McKew', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Concord Repatriation and General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2305', 'city': 'Newcastle', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Joshua Davis, MD PhD', 'role': 'CONTACT', 'email': 'Joshua.Davis@health.nsw.gov.au'}, {'name': 'Joshua Davis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': "Matthew O'Sullivan, MD", 'role': 'CONTACT', 'email': 'matthew.osullivan@health.nsw.gov.au'}, {'name': "Matthew O'Sullivan, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Bridget Barber, MD', 'role': 'CONTACT', 'email': 'Bridget.Barber@qimrberghofer.edu.au'}, {'name': 'Bridget Barber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nicholas Anagnostou, MD', 'role': 'CONTACT', 'email': 'nicholas.anagnostou@sa.gov.au'}, {'name': 'Nicholas Anagnostou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Stephen Guy, MD', 'role': 'CONTACT', 'email': 'stephen.guy@easternhealth.org.au'}, {'name': 'Steven Guy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Box Hill Hospital', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Ben Rogers, MD PhD', 'role': 'CONTACT', 'email': 'ben.rogers@monash.edu'}, {'name': 'Ben Rogers, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monash Medical Campus (Monash Medical Centre + Jesse McPherson Private Hospital)', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Justin Denholm, MD', 'role': 'CONTACT', 'email': 'justin.denholm@mh.org.au'}, {'name': 'Justin Denholm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6150', 'city': 'Murdoch', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Owen Robinson, MD', 'role': 'CONTACT', 'email': 'owen.robinson@health.wa.gov.au'}, {'name': 'Owen Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Owen Robinson, MD', 'role': 'CONTACT', 'email': 'owen.robinson@health.wa.gov.au'}, {'name': 'Owen Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'V3V1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christopher Condin, PhD', 'role': 'CONTACT', 'email': 'christopher.condin@fraserhealth.ca'}, {'name': 'Kevin Afra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fraser Health Authority (Surrey Memorial Hospital)', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'city': "St. John's", 'state': 'Newfoundland and Labrador', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Daly, MD', 'role': 'CONTACT', 'email': 'pkd336@mun.ca'}, {'name': 'Peter Daly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Newfoundland Health Services (Health Sciences Centre and St. Clare's Mercy Hospital)", 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'H4A3S1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lina Petrella', 'role': 'CONTACT', 'email': 'lina.petrella@muhc.mcgill.ca', 'phone': '5149341934', 'phoneExt': '23730'}, {'name': 'Todd C Lee, MD MPH FIDSA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emily G McDonald, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthew P. Cheng, MD SM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Lina Petrella', 'role': 'CONTACT', 'email': 'lina.petrella@muhc.mcgill.ca', 'phone': '514-934-1934', 'phoneExt': '23730'}], 'overallOfficials': [{'name': 'Todd C Lee, MD MPH FIDSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data sharing policies are dependent on the policies of the SNAP Platform (NCT05137119)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Todd C. Lee MD MPH FIDSA', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Melbourne', 'class': 'OTHER'}, {'name': 'The Peter Doherty Institute for Infection and Immunity', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Todd C. Lee MD MPH FIDSA', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}