Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06801405
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2025-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-24', 'releaseDate': '2025-04-04'}, {'resetDate': '2025-05-13', 'releaseDate': '2025-04-27'}, {'resetDate': '2025-08-22', 'releaseDate': '2025-08-06'}, {'resetDate': '2025-09-18', 'releaseDate': '2025-08-31'}], 'estimatedResultsFirstSubmitDate': '2025-04-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014517', 'term': 'Ureteral Obstruction'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-18', 'studyFirstSubmitQcDate': '2025-01-24', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary tract infection rate', 'timeFrame': 'Up to 7 days after percutaneous nephrostomy', 'description': 'Proportion of urinary tract infection after each percutaneous nephrostomy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic prophylaxis', 'percutaneous nephrostomy', 'urinary tract infections', 'cancer patients'], 'conditions': ['Ureteral Obstruction', 'Neoplasms', 'Acute Kidney Injury', 'Nephrostomy; Complications', 'Antibiotic Prophylaxis', 'Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.', 'detailedDescription': "The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.\n\nDefinitions:\n\nUrinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).\n\nUTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.\n\nUTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.\n\nAntibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.\n\nFor the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.\n\nFor catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.\n\nPercutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for cancer who required percutaneous nephrostomies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated for cancer who required percutaneous nephrostomies\n\nExclusion Criteria:\n\n* Patients and/or procedures if percutaneous nephrostomy was used to perform other procedures;\n* Patients and/or procedures if percutaneous nephrostomy was used to treat clinical conditions other than malignant ureteral obstruction\n* Patients and/or procedures if percutaneous nephrostomy was used to clear the urinary tract of non-malignant causes'}, 'identificationModule': {'nctId': 'NCT06801405', 'briefTitle': 'Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Barretos Cancer Hospital'}, 'officialTitle': 'Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction. A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '44395921.4.0000.5437'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No antibiotic prophylaxis (NAP) - Group', 'description': 'No antibiotic prophylaxis before percutaneous nephrostomy'}, {'label': 'Antibiotic prophylaxis (AP) - Group', 'description': 'With antibiotic prophylaxis before percutaneous nephrostomy', 'interventionNames': ['Drug: antibiotic prophylaxis']}], 'interventions': [{'name': 'antibiotic prophylaxis', 'type': 'DRUG', 'description': 'Antibiotic prophylaxis before percutaneous nephrostomy', 'armGroupLabels': ['Antibiotic prophylaxis (AP) - Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706-396', 'city': 'Jales', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Jales Cancer Hospital', 'geoPoint': {'lat': -20.26889, 'lon': -50.54583}}], 'overallOfficials': [{'name': 'Ricardo RD Reis', 'role': 'STUDY_CHAIR', 'affiliation': 'Barretos Cancer Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'For an indefinite period', 'ipdSharing': 'YES', 'description': 'Publication in a peer-reviewed journal and release of data upon plausible justification', 'accessCriteria': 'Justification sent by e-mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barretos Cancer Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeferson Rodrigo Zanon', 'investigatorAffiliation': 'Barretos Cancer Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-04', 'type': 'RELEASE'}, {'date': '2025-04-24', 'type': 'RESET'}, {'date': '2025-04-27', 'type': 'RELEASE'}, {'date': '2025-05-13', 'type': 'RESET'}, {'date': '2025-08-06', 'type': 'RELEASE'}, {'date': '2025-08-22', 'type': 'RESET'}, {'date': '2025-08-31', 'type': 'RELEASE'}, {'date': '2025-09-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jeferson Rodrigo Zanon, Principal Investigator, Barretos Cancer Hospital'}}}}