Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 1:40 PM
Study NCT ID:
NCT04502095
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2020-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], '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': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D000077727', 'term': 'Ertapenem'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D009582', 'term': 'Nitrofurantoin'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '90-day urinary tract infection (UTI) status', 'timeFrame': 'At 90 days after surgery', 'description': 'Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.'}], 'secondaryOutcomes': [{'measure': 'Identify pre-operative factors associated with the development of UTI', 'timeFrame': 'Up to 120 days after surgery', 'description': 'stratified logistic regression models (stratified by antibiotic use)'}, {'measure': 'Development of Clostridium difficile (C Diff)', 'timeFrame': 'up to 120 days after surgery', 'description': 'Will be evaluated in patients who received prophylactic antibiotics.'}, {'measure': 'Infections occurring during antibiotic use', 'timeFrame': 'Up to 120 days after surgery', 'description': "To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively."}, {'measure': 'Identify post operative factors associated with the development of UTI', 'timeFrame': 'Up to 120 days after surgery', 'description': 'stratified logistic regression models (stratified by antibiotic use)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Carcinoma', 'Refractory Bladder Carcinoma', 'Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.\n\nSECONDARY OBJECTIVE:\n\nI. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I (ANTIBIOTIC): Patients receive ertapenem Intravenously (IV), levofloxacin, or clindamycin IV at induction per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.\n\nGROUP II (CONTROL): Patients receive ertapenem IV, levofloxacin IV or clindamycin IV at induction per standard of care.\n\nAfter surgery, patients are followed up to 120 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC)\n* Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent\n* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with a history of myasthenia gravis\n* Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded\n* Patients with renal dysfunction, creatinine clearance (mL/min) \\< 30\n* Pregnant or nursing female participants\n* Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)\n* Unwilling or unable to follow protocol requirements\n* Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug"}, 'identificationModule': {'nctId': 'NCT04502095', 'briefTitle': 'Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy', 'orgStudyIdInfo': {'id': 'I 573720'}, 'secondaryIdInfos': [{'id': 'NCI-2020-04928', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I 573720', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)', 'description': 'Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.', 'interventionNames': ['Drug: Clindamycin', 'Other: Diary', 'Drug: Ertapenem', 'Drug: Levofloxacin', 'Drug: Nitrofurantoin', 'Drug: Trimethoprim-Sulfamethoxazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (standard of care)', 'description': 'Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.', 'interventionNames': ['Drug: Clindamycin', 'Drug: Ertapenem', 'Drug: Levofloxacin']}], 'interventions': [{'name': 'Clindamycin', 'type': 'DRUG', 'otherNames': ['Cleocin'], 'description': 'Given PO', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)', 'Group II (standard of care)']}, {'name': 'Diary', 'type': 'OTHER', 'description': 'Complete drug diary', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)']}, {'name': 'Ertapenem', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)', 'Group II (standard of care)']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1)', 'Levaquin', 'Levofloxacin Hydrate', 'Quixin'], 'description': 'Given PO', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)', 'Group II (standard of care)']}, {'name': 'Nitrofurantoin', 'type': 'DRUG', 'otherNames': ['Macrobid', 'Macrodantin'], 'description': 'Given PO', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)']}, {'name': 'Trimethoprim-Sulfamethoxazole', 'type': 'DRUG', 'otherNames': ['Bactrim', 'Bactrim DS', 'Bactrimel', 'Centran', 'Centrin', 'Co-Trimoxazole', 'Cotrim', 'Cotrimoxazole', 'Eslectin', 'Insozalin', 'Septra', 'SMZ-TMP', 'Sulfamethoprim', 'Sulfatrim', 'Sulmeprim', 'TMP-SMX', 'Trimedin', 'Trimezole', 'Uroplus'], 'description': 'Given PO', 'armGroupLabels': ['Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Khurshid A Guru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}