Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-04-19 @ 4:46 AM
Study NCT ID:
NCT02375295
Status:
UNKNOWN
Last Update Posted:
2022-05-17
First Post:
2015-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Struvite Stones Antibiotic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002137', 'term': 'Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney 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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D009582', 'term': 'Nitrofurantoin'}, {'id': 'D002506', 'term': 'Cephalexin'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'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'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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': '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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-16', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'any recurrent kidney stones', 'timeFrame': '6 months', 'description': 'Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.'}], 'secondaryOutcomes': [{'measure': 'UTI', 'timeFrame': '1 year', 'description': 'Positive urine cultures at any point within 1 year from surgical therapy.'}, {'measure': 'treated site stone recurrence rates', 'timeFrame': '1 year', 'description': 'Radiologic recurrence of calculi in the location of original treatment at or before 12 months following definitive surgical therapy'}, {'measure': 'Clostridiuum difficile colitis', 'timeFrame': '1 year', 'description': 'Antibiotic related complications such as Clostridiuum difficile colitis infections.'}, {'measure': 'ER visit', 'timeFrame': 'POD1', 'description': 'In hospital sepsis and febrile episodes.'}, {'measure': 'Readmission for sepsis.', 'timeFrame': '3 months', 'description': 'Readmission for sepsis.'}, {'measure': 'Readmission for renal colic', 'timeFrame': '3 months', 'description': 'Readmission for renal colic'}, {'measure': 'Morbidity or mortality related to sepsis or renal failure', 'timeFrame': '3 months', 'description': 'Morbidity or mortality related to sepsis or renal failure'}, {'measure': 'Repeat surgical procedures for stone recurrence', 'timeFrame': '3 months', 'description': 'Repeat surgical procedures for stone recurrence'}, {'measure': 'Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes', 'timeFrame': '3 months', 'description': 'Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['struvite', 'infection', 'stones', 'calculi', 'antibiotics'], 'conditions': ['Kidney Stones']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).', 'detailedDescription': 'Struvite stones or infection stones are a subset of kidney stones that are related to bacterial infection. They only make up 15% of all kidney stones, but account for a much higher percentage of mortality (up to 67%) compared to other stones-due to the infectious component. Treatment is to ensure 100% eradication of the stone with surgery followed by antibiotics to eliminate the infection. Failure to eliminate the bacteria results in the stone growing back quickly. It is unknown how long antibiotics should be administered immediately after surgery-some urologists give 2-4 weeks while others give 2-3 months. We seek to randomize patients to receive 2 weeks of antibiotics or 3 months of antibiotics after surgery to remove all the kidney stones. We will see patients at 3, 6, and 12 months with x-rays and to test their urine for bacterial infections. This is a multi-centre study with participating 12 sites across North America.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female.\n2. No age restriction.\n3. Diagnosed with an infection related stone.\n4. Medically fit for definitive surgical management of stone.\n5. Life expectancy greater than one year.\n6. Stone free after definitive surgical therapy defined as fragments less than 3mm.\n\nExclusion Criteria:\n\n1. Patients with medical comorbidities preventing them from definitive surgical therapy.\n2. Patients with persistent stone burden following definitive surgical therapy.'}, 'identificationModule': {'nctId': 'NCT02375295', 'briefTitle': 'Struvite Stones Antibiotic Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones', 'orgStudyIdInfo': {'id': 'H13-02514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: 2 weeks Abx post PCNL', 'description': 'Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.', 'interventionNames': ['Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: 12 weeks/3 months Abx post PCNL', 'description': 'Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose followed by a suppressive dose for another 10 weeks (total = 12 weeks or 3 months).', 'interventionNames': ['Drug: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin']}], 'interventions': [{'name': 'ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin', 'type': 'DRUG', 'otherNames': ['Keflex, Macrobid, co-trimoxazole'], 'description': "Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin", 'armGroupLabels': ['Arm A: 2 weeks Abx post PCNL', 'Arm B: 12 weeks/3 months Abx post PCNL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mitchell Humphreys, MD', 'role': 'CONTACT', 'email': 'Humphreys.Mitchell@mayo.edu'}], 'facility': 'Mayo Clinic - Scottsdale/Phoenix, AZ', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roger Sur, MD', 'role': 'CONTACT', 'email': 'rlsur@mail.ucsd.edu'}], 'facility': 'University California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Matlaga', 'role': 'CONTACT', 'email': 'bmatlag1@jhmi.edu'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114-3117', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Eisner, MD', 'role': 'CONTACT', 'email': 'BEISNER@PARTNERS.ORG'}], 'facility': 'Harvard University - Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Krambeck, MD', 'role': 'CONTACT', 'email': 'krambeck.amy@mayo.edu'}], 'facility': 'Mayo Clinic - Rochester, MN', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '03756-0001', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vernon Pais, MD', 'role': 'CONTACT', 'email': 'Vernon.M.Pais.Jr@hitchcock.org'}], 'facility': 'Dartmouth University', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ojas Shah, MD', 'role': 'CONTACT', 'email': 'Ojas.Shah@nyumc.org'}], 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Lipkin, MD', 'role': 'CONTACT', 'email': 'michael.lipkin@duke.edu'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bodo Knudsen, MD', 'role': 'CONTACT', 'email': 'Bodo.Knudsen@osumc.edu'}, {'name': 'Janet McGarr', 'role': 'CONTACT', 'email': 'Janet.Mcgarr@osumc.edu'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Manoj Monga, MD', 'role': 'CONTACT', 'email': 'mongam@ccf.org'}], 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Miller, MD', 'role': 'CONTACT', 'email': 'nicole.miller@Vanderbilt.Edu'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olga Arsovska', 'role': 'CONTACT', 'email': 'olga.arsovska@ubc.ca', 'phone': '604 875 4111', 'phoneExt': '62421'}, {'name': 'Ben Chew, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dirk Lange, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ryan Flannigan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ryan Paterson, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elspeth McDougall, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Stone Centre, VGH/UBC', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Olga Arsovska', 'role': 'CONTACT', 'email': 'olga.arsovska@ubc.ca', 'phone': '6048754111', 'phoneExt': '62421'}], 'overallOfficials': [{'name': 'Ben Chew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ben Chew, MD', 'investigatorAffiliation': 'University of British Columbia'}}}}