Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-04 @ 3:44 AM
Study NCT ID:
NCT05447559
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants, treating clinicians, all members of the research team including the study statistician will be blinded to treatment arm allocation.\n\nActive treatment will consist of 2-grams cefazolin powder for injection. Placebo will consist of an identical empty vial. The commercial labels will be removed and a sheath placed over the vial. Amber-tinted syringes will be provided for drawing up and administration of cefazolin/placebo to mask study arm.\n\nThe vial containing cefazolin or placebo will be reconstituted in a minimum of 10 mL of sterile water for injections and administered in keeping with product information for cefazolin and / or local guidelines.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Antimicrobial hypersensitivity reactions', 'timeFrame': 'From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery', 'description': 'Immediate (\\<48 hrs after exposure) or delayed (≥24 hrs after exposure) reaction to study drug'}, {'measure': 'All-cause mortality rate', 'timeFrame': '180 days from index surgery', 'description': 'Death reported up to 180 days from index cardiac surgery due to any cause.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': 'From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery', 'description': 'AKI will be defined according to the RIFLE criteria'}, {'measure': 'Incidence of surgical site infections due to drug-resistant infections', 'timeFrame': '90 days from index surgery', 'description': 'Surgical site infections due to drug-resistant infections (defined as resistance to cefazolin)'}], 'primaryOutcomes': [{'measure': 'Incidence of surgical site infection', 'timeFrame': '90 days from index surgery', 'description': 'Surgical site infection according to CDC / NHSN definition'}], 'secondaryOutcomes': [{'measure': 'Incidence of Clostridioides difficile infection', 'timeFrame': '30 days from index surgery', 'description': 'Clostridioides difficile infection according the CDC definitions'}, {'measure': 'Incidence of other health care association infections', 'timeFrame': 'From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery', 'description': 'Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac surgery'], 'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery', 'detailedDescription': 'This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery.\n\nCALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare:\n\nArm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Adult patients undergoing cardiac surgery involving a median sternotomy\n\nExclusion Criteria:\n\n* Age \\<18 years\n* American Society of Anesthesiology (ASA) 5\n* Subjects with GFR \\<40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis\n* Surgery for suspected or proven endocarditis or deep sternal wound infection\n* Documented cefazolin hypersensitivity\n* Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery\n* Cardiac transplantation\n* Procedures involving insertion ventricular assist device or mechanical circulatory support device\n* Procedures not involving a median sternotomy\n* Patients previously enrolled and randomised to the CALIPSO trial'}, 'identificationModule': {'nctId': 'NCT05447559', 'acronym': 'CALIPSO', 'briefTitle': 'Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery', 'orgStudyIdInfo': {'id': '228/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Intraoperative only Surgical Antimicrobial Prophylaxis Arm', 'description': 'Placebo administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses', 'interventionNames': ['Drug: Water for injection']}, {'type': 'OTHER', 'label': 'Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm', 'description': 'Cefazolin (2g) administered 8-hourly following the preoperative dose (time=0) for two doses then placebo 8-hourly for three doses (total of 5 postoperative doses of cefazolin/placebo)', 'interventionNames': ['Drug: Cefazolin', 'Drug: Water for injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm', 'description': 'Cefazolin (2g) administered every 8-hours following the preoperative dose (time=0) for a total of five postoperative doses', 'interventionNames': ['Drug: Cefazolin']}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Intravenous administration of 2 g cefazolin', 'armGroupLabels': ['Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm', 'Intraoperative and 48-hours Postoperative Surgical Antimicrobial Prophylaxis Arm']}, {'name': 'Water for injection', 'type': 'DRUG', 'description': 'Intravenous administration of 10mL sterile water for injection', 'armGroupLabels': ['Intraoperative and 24-hours Postoperative Surgical Antimicrobial Prophylaxis Arm', 'Intraoperative only Surgical Antimicrobial Prophylaxis Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Louise Cope', 'role': 'CONTACT'}, {'name': 'Alison Williams', 'role': 'CONTACT'}], 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2217', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'St George Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4032', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': "Donalee O'Brien", 'role': 'CONTACT', 'email': 'Donalee.Obrien@health.qld.gov.au', 'phone': '+6131394130'}, {'name': 'Mbakise Matebele', 'role': 'CONTACT'}], 'facility': 'The Prince Charles Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4102', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Allison Kearney', 'role': 'CONTACT', 'email': 'allison.kearney@healh.qld.gov.au'}, {'name': 'David Highton', 'role': 'CONTACT'}], 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kate Drummond', 'role': 'CONTACT', 'email': 'kate.drummond@sa.gov.au'}, {'name': 'Kate Drummond', 'role': 'CONTACT'}], 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rhys Hamson', 'role': 'CONTACT', 'email': 'Rhys.Hamson@sa.gov.au'}, {'name': 'Rob Baker', 'role': 'CONTACT'}], 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rhys Hamson', 'role': 'CONTACT', 'email': 'Rhys.Hamson@sa.gov.au'}, {'name': 'Rob Baker', 'role': 'CONTACT'}], 'facility': 'Flinders Private', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '7000', 'city': 'Hobart', 'state': 'Tasmania', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Robyn Seale', 'role': 'CONTACT', 'email': 'researchanaesdept@ths.tas.gov.au'}, {'name': 'Michael Challis', 'role': 'CONTACT'}], 'facility': 'Royal Hobart Hospital', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sarah Astbury', 'role': 'CONTACT', 'email': 'sarah.astbury@monash.edu', 'phone': '+61399039261'}, {'name': 'Sarah Robertshaw', 'role': 'CONTACT', 'email': 's.robertshaw@alfred.org.au', 'phone': '+61390763709'}, {'name': 'Silvana Marasco', 'role': 'CONTACT'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jingfei Wu', 'role': 'CONTACT', 'email': 'research@heartweb.com'}, {'name': 'Alistair Royse', 'role': 'CONTACT'}], 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3084', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Gayle Claxton', 'role': 'CONTACT', 'email': 'Gayle.CLAXTON@austin.org.au'}, {'name': 'Lachlan Miles', 'role': 'CONTACT'}], 'facility': 'Austin Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3121', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nicole Tan', 'role': 'CONTACT', 'email': 'niki.tan@anaestheticservices.com.au'}, {'name': 'Nicole Tan', 'role': 'CONTACT'}], 'facility': 'Epworth HealthCare', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3128', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nicole Tan', 'role': 'CONTACT', 'email': 'niki.tan@anaestheticservices.com.au'}, {'name': 'Nicole Tan', 'role': 'CONTACT'}], 'facility': 'Epworth Eastern HealthCare', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3144', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Lisa Dougherty', 'role': 'CONTACT', 'email': 'icuresearch@cabrini.com.au'}, {'name': 'Vineet Sarode', 'role': 'CONTACT'}], 'facility': 'Cabrini Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Amanda Hulley', 'role': 'CONTACT', 'email': 'Amanda.Hulley@monashhealth.org', 'phone': '+61385722652'}, {'name': 'Julian Smith', 'role': 'CONTACT'}], 'facility': 'Victorian Heart Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Nedlands', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Peri Mickle', 'role': 'CONTACT', 'email': 'peri.mickle@health.wa.gov.au', 'phone': '+61 (08) 6457 7220'}, {'name': 'James Preuss', 'role': 'CONTACT'}], 'facility': 'Sir Charles Gairdner', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '6008', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Yvonne Buller', 'role': 'CONTACT', 'email': 'yvonne.buller@sjog.org.au'}, {'name': 'Tomas Corcoran', 'role': 'CONTACT'}], 'facility': 'St John of God Subiaco Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Perth', 'state': 'Western Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rebecca Hahn', 'role': 'CONTACT', 'email': 'Rebecca.hahn@health.wa.gov.au', 'phone': '+616152 5944'}, {'name': 'Ulrich Stock', 'role': 'CONTACT'}], 'facility': 'Fiona Stanley Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Melbourne', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Dima Jayaratne', 'role': 'CONTACT', 'email': 'dima.jayaratne@svha.org.au', 'phone': '+61 3 9231 4245'}, {'name': 'David Scott', 'role': 'CONTACT'}], 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Christchurch', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Jan Mehrtens', 'role': 'CONTACT', 'email': 'Jan.Mehrtens@cdhb.health.nz', 'phone': '+64 (03)3640 640'}, {'name': 'Jay Ritzema-Carter', 'role': 'CONTACT'}], 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '3204', 'city': 'Hamilton', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Jonathon Termaat', 'role': 'CONTACT', 'email': 'Jonathan.Termaat@waikatodhb.health.nz'}, {'name': 'Kelly Byrne', 'role': 'CONTACT'}], 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Wellington', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Leanlove Navarra', 'role': 'CONTACT', 'email': 'Leanlove.Navarra@ccdhb.org.nz', 'phone': '+64 27 553 1488'}, {'name': 'Daniel Frei', 'role': 'CONTACT'}], 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'centralContacts': [{'name': 'Paige Druce, MSc(Epi)', 'role': 'CONTACT', 'email': 'paige.druce@monash.edu', 'phone': '9903 0016', 'phoneExt': '+61 3'}, {'name': 'Sarah Astbury', 'role': 'CONTACT', 'email': 'sarah.astbury@monash.edu', 'phone': '9076 6071', 'phoneExt': '+61 3'}], 'overallOfficials': [{'name': 'Trisha Peel, MBBS GradCertRes FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Australian and New Zealand College of Anaesthetists (ANZCA)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Trisha Peel', 'investigatorFullName': 'Trisha Nicole Peel', 'investigatorAffiliation': 'Monash University'}}}}