Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 7:25 PM
Study NCT ID:
NCT05392634
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2022-05-22', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event rate', 'timeFrame': '90 days after Radical cystectomy', 'description': 'Determine the frequency of events of clinical interest in the period 30-90 days after RC in a surgical hospital working according to the protocol for early postoperative recovery of the patient'}, {'measure': 'Event-free survival', 'timeFrame': '90 days after Radical cystectomy', 'description': 'Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital'}], 'secondaryOutcomes': [{'measure': 'Emergence of resistant', 'timeFrame': '30-90 days after Radical cystectomy', 'description': 'To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis'}, {'measure': 'All-cause mortality', 'timeFrame': '90 days after Radical cystectomy', 'description': 'Establish the frequency of 30-day, 90-day all-cause mortality after RC in a surgical hospital working according to the protocol for early postoperative patient recovery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radical cystectomy', 'antibiotic prophylaxis', 'ERAS protocol', 'muscle-invasive bladder cancer', 'urinary diversion'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '39355793', 'type': 'DERIVED', 'citation': 'Berkut MV, Belyaev AM, Galunova TY, Tyapkin NI, Reva SA, Nosov AK. Prolonged 120-h meropenem antibiotic prophylaxis in radical cystectomy compared to 24h standard antibiotic prophylaxis: Final analysis of the randomized clinical trial. Arab J Urol. 2024 Jul 3;22(4):235-242. doi: 10.1080/20905998.2024.2373399. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation.\n\nResearch hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (cT1NoMo) or muscle-invasive bladder carcinoma (cT2-T4NxM0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible);\n* patient should be eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy or hysterectomy if applicable) according to surgeon opinion;\n* pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation;\n* urinary diversion is engaged in two possible variants: orthotopic diversion (J- or U-pouch reservoirs), heterotopic diversion in the Mainz-I modification, Bricker;\n* male or female is at least 18 years old at the time of signing the informed consent form;\n* female patient is eligible to participate if she is not pregnant, not breastfeeding;\n* ECOG performance status of 0 or 1;\n* adequate organ function (in accordance with laboratory standards);\n* used valid protocol for Enhanced Recovery After Surgery (ERAS protocol) at Hospital (oncourological department);\n\nExclusion Criteria:\n\n* known additional non-urothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions;\n* diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;\n* replacement doses of corticosteroids are permitted for participants with adrenal insufficiency;\n* evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion;\n* presence of 2 or more criteria for systemic inflammatory response syndrome (SIRS) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization):\n\n * temperature ≥ 38˚С or ≤ 36˚С;\n * heart rate (HR) ≥ 90 / min;\n * respiratory rate \\< 20/min or hyperventilation (Pa CO2 ≤ 32 mm Hg);\n * blood leukocytes \\>12 ∙ 109 / l or \\< 4 ∙ 109 / l, or immature forms \\> 10%\n* prohibited urinary diversion when planning surgery and signing voluntary consent: diversion into continuous intestine (ureterosigmostomy, Mainz-pouch II operation);\n* inadequate organ function:\n\n * Neutrophils \\<1.5 x 10 \\^ 9 / l\n * Platelets \\<100 x 10 \\^ 9 / l\n * ALT\\> 3 x VGN\n * AST\\> 3 x VGN\n * Bilirubin\\> 1.5 x ULN\n * GFR level \\<35 ml / min"}, 'identificationModule': {'nctId': 'NCT05392634', 'acronym': 'MACS', 'briefTitle': 'Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'N.N. Petrov National Medical Research Center of Oncology'}, 'officialTitle': 'Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol', 'orgStudyIdInfo': {'id': 'MACS-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin/ Cefuroksim', 'description': 'standard antibiotic prophylaxis 24 hours', 'interventionNames': ['Drug: Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg']}, {'type': 'EXPERIMENTAL', 'label': 'Meropenem', 'description': 'preventive antibiotic therapy within 5 days from the date of the skin incision', 'interventionNames': ['Drug: Meropenem 1000 mg']}], 'interventions': [{'name': 'Meropenem 1000 mg', 'type': 'DRUG', 'description': 'Group B: prolonged antibiotic prophylaxis \\>72 hours (5 days) from the moment of the skin incision in accordance with the selected clinic drug + correction of the appointment based on clinical events after 5 days.', 'armGroupLabels': ['Meropenem']}, {'name': 'Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg', 'type': 'DRUG', 'description': 'Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;', 'armGroupLabels': ['Amoxicillin/ Cefuroksim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197758', 'city': 'Saint Petersburg', 'state': 'Sankt-Peterburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Mariya Berkut, PhD', 'role': 'CONTACT', 'email': 'berkutv91@gmail.com', 'phone': '89312870497'}], 'facility': 'FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Mariya Berkut, PhD', 'role': 'CONTACT', 'email': 'berkutv91@gmail.com', 'phone': '+79312870497'}], 'overallOfficials': [{'name': 'Mariya Berkut, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'N.N. Petrov National Medical Research Center of Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Foundation for Cancer Research Support (RakFond)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Berkut Mariya', 'investigatorAffiliation': 'N.N. Petrov National Medical Research Center of Oncology'}}}}