Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT04212403
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2019-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], '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'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2019-08-06', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of patients with a post-operative infection.', 'timeFrame': 'From immediately post-op until at the control consultation 4 weeks after surgery.', 'description': 'Urosepsis, fever (t°\\> 38.5) or epididymitis.'}], 'secondaryOutcomes': [{'measure': 'Incidence of post-operative bacteriuria.', 'timeFrame': 'From immediately post-op until at the control consultation 4 weeks after surgery.', 'description': '\\> 100.000 bacteria/mL urine'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TURP', 'TURB'], 'conditions': ['Urosepsis', 'Bladder Cancer', 'Prostate Hyperplasia', 'Antibiotic Resistant Strain', 'Antibiotic Resistant Infection', 'Antibiotic-associated Diarrhea', 'Antibiotic Toxicity']}, 'descriptionModule': {'briefSummary': 'To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \\> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.', 'detailedDescription': 'Main objective:\n\nTo investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \\> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).\n\nSecondary objective:\n\nTo investigate post-operative bacteriuria after TURB and TURP in our population.\n\nPrincipal inclusion criterium:\n\nPatients undergoing TURP or TURB.\n\nPrimary exclusion criterium:\n\nTURP: pre-operative catheter or \\> 100 white blood cells in the pre- operative urinary sample.\n\nTURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).\n\nPrimary endpoint:\n\nPost-operative infection.\n\nSecondary endpoint:\n\nPost-operative bacteriuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TURP or TURB.\n\nExclusion Criteria:\n\n* TURP: pre-operative catheter/DJ/nephrostomy or \\> 100 white blood cells in the pre- operative urinary sample.\n\nTURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).'}, 'identificationModule': {'nctId': 'NCT04212403', 'acronym': 'Prophylaxis001', 'briefTitle': 'Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial', 'orgStudyIdInfo': {'id': 'JessaH_B243201733480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment group', 'description': 'The treatment group receives no AMP.'}], 'interventions': [{'name': 'Levofloxacin', 'type': 'DRUG', 'description': 'The control group receives AMP.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Koenraad van Renterghem, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UHasselt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}