Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
Study NCT ID:
NCT07209150
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019072', 'term': 'Antibiotic Prophylaxis'}], 'ancestors': [{'id': 'D018890', 'term': 'Chemoprevention'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011292', 'term': 'Premedication'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who are eligible to undergo HoLEP and have an indwelling urinary catheter or perform CIC will be randomized to different durations of peri-operative antibiotic prophylaxis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infectious complications', 'timeFrame': '0-90 days postoperatively', 'description': 'UTI, pyelonephritis, sepsis, hospital admission, ED visits'}], 'secondaryOutcomes': [{'measure': 'healthcare utilization', 'timeFrame': '0-90days', 'description': 'hospital admission or ED visits occurring post HoLEP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bph', 'urinary retention', 'antibiotic prophylaxis'], 'conditions': ['BPH With Urinary Obstruction', 'Antibiotic Prophylaxis']}, 'descriptionModule': {'briefSummary': 'To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Candidate for HoLEP surgery 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol.\n\nExclusion Criteria:\n\n* 1\\. Under the age of 18 2. Refuse to provide informed consent 3. Anticipated need for perineal urethrostomy 4. History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents'}, 'identificationModule': {'nctId': 'NCT07209150', 'briefTitle': 'Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Randomized Controlled Trial of 3 vs 7 Days for Perioperative Antibiotic Prophylaxis for Patients With an Indwelling Catheter Prior to Holmium Laser Enucleation of the Prostate', 'orgStudyIdInfo': {'id': '2025HoLEP_periopabx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 day prophylaxis', 'description': '3 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 1 day prior to surgery). macrobid if preoperative culture is negative', 'interventionNames': ['Drug: antibiotic prophylaxis']}, {'type': 'OTHER', 'label': '7 day prophylaxis', 'description': '7 days of perioperative culture directed antibiotic prophylaxis will be prescribed to this group (to start 4 day prior to surgery). macrobid if preoperative culture is negative', 'interventionNames': ['Drug: antibiotic prophylaxis']}], 'interventions': [{'name': 'antibiotic prophylaxis', 'type': 'DRUG', 'description': 'we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery', 'armGroupLabels': ['3 day prophylaxis', '7 day prophylaxis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Matthew Lee, MD', 'role': 'CONTACT', 'email': 'matthew.lee@osumc.edu', 'phone': '614-293-8155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}