Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-19 @ 9:21 PM
Study NCT ID:
NCT02579161
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney 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': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D002437', 'term': 'Cefazolin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zokeke@northwell.edu', 'phone': '516-734-8500', 'title': 'Dr. Zeph Okeke', 'organization': 'Northwell Health'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Procedure included tubeless procedures. While this may aid in generalizability, an element of antibiotic duration variation is unavoidably introduced in this treatment arm. The original design was to have 290 participants, due to the low number of recruitment, this number was reduced to a goal of 100 total with 50 randomized to each arm. This limits the analysis, but ultimately desired measures were achieved.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events occurring within the first 30 post-operative days were recorded for each patient.', 'description': 'The primary outcome was the rate of postoperative sepsis further stratified by presence of body temperature \\>38 degrees Celsius, positive SIRS criteria, bacteremia, or bacteriuria. Adverse events are graded according to Clavien dindo scale, I-V with increasing severity up to V, which is patient death. Serious adverse events are defined by Clavien IIIb or higher, which is defined as requiring an additional procedure with general anesthesia.', 'eventGroups': [{'id': 'EG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 9, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 10, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'fevers post operative', 'notes': 'readmitted for fevers requiring additional antibiotic treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo II'}, {'term': 'Post operative urinary retention', 'notes': 'Urinary retention requiring foley catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo I'}, {'term': 'Post operative pain', 'notes': 'return to emergency room for post operative flank pain, resolved with conservative management.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo I'}, {'term': 'Post operative anemia requiring transfusion', 'notes': 'Post operative bleeding requiring transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo I'}, {'term': 'Post-operative embolization', 'notes': 'post operative delayed bleeding requiring embolization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo IIIa'}], 'seriousEvents': [{'term': 'Hemothorax/Pneumothorax', 'notes': 'Puncture of diaphragm during procedure leading to blood or air filling pleural space. This requires patient to have a chest tube placement.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}, {'term': 'Fevers with Hydronephrosis', 'notes': 'Post surgical fever with associated hydronephrosis indicates blockage of upper tracts requiring drainage with ureteral stent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien-Dindo'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Infectious Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'OG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'SIRS', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Bacteriuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bacteremia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-30 days post-operatively', 'description': 'Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure while those in the control arm received antibiotics until external catheters were removed based on surgeon preference'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'OG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-30 days post operatively', 'description': 'Length of Hospital Stay After Surgery (days)', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Associated Clavien Grade of Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'OG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}], 'classes': [{'title': 'Grade I', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade II', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade IIIA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade IIIB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 30 days after surgery', 'description': 'Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication.\n\nGrade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention.\n\nGrade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'FG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Antibiotics for a 24 Hour Period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'BG001', 'title': 'Continued Antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.\n\ncephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication\n\naminoglycoside\n\nmetronidazole\n\nClindamycin\n\naminoglycoside/ sulbactam: If allergies to above medicines\n\nFluoroquinolones'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.1', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '58.9', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-18', 'size': 417560, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-29T18:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2014-06-19', 'resultsFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-13', 'studyFirstPostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Infectious Complications', 'timeFrame': '0-30 days post-operatively', 'description': 'Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (Days)', 'timeFrame': '0-30 days post operatively', 'description': 'Length of Hospital Stay After Surgery (days)'}, {'measure': 'Number of Participants With Associated Clavien Grade of Adverse Event', 'timeFrame': '0 to 30 days after surgery', 'description': 'Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication.\n\nGrade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention.\n\nGrade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous Nephrolithotomy', 'Kidney Stones', 'Antibiotics'], 'conditions': ['Kidney Stones']}, 'referencesModule': {'references': [{'pmid': '37578113', 'type': 'DERIVED', 'citation': 'Griffiths L, Aro T, Samson P, Derisavifard S, Gaines J, Alaiev D, Mullen G, Rai A, Williams T, Patel V, Guanay G, Leavitt D, Hartman C, Smith A, Hoenig D, Okeke Z. Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients. J Endourol. 2023 Oct;37(10):1075-1080. doi: 10.1089/end.2022.0678.'}]}, 'descriptionModule': {'briefSummary': 'The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.', 'detailedDescription': "For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.\n\nThe investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.\n\nAntibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone\n\nLooking at the same drugs and doses the variable is the timeframe of the medication"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years old\n* Negative urine culture within 1 month prior to procedure\n* Renal Calculi which would optimally require PCNL for treatment.\n\nExclusion Criteria:\n\n* Patients \\<18 years old.\n* Patients who are not able to give consent for study\n* Patients currently on antibiotics immediately prior to the procedure\n* Previous history of sepsis or SIRS from stone manipulations\n* Foley catheter in place for greater than 1 week duration\n* Patients under going planned, multi-staged procedures\n* Immunosuppressed patients'}, 'identificationModule': {'nctId': 'NCT02579161', 'briefTitle': 'Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy', 'orgStudyIdInfo': {'id': '14-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotics for a 24 hour period', 'description': 'Antibiotics for a 24 hour period\n\nIntervention drug to be determined based on patient history etc.', 'interventionNames': ['Drug: cephalosporins', 'Drug: Fluoroquinolones', 'Drug: Clindamycin', 'Drug: Ampicillin/Gentamicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continued antibiotics', 'description': 'Continued antibiotics until the removal of any external catheters\n\nIntervention drug to be determined based on patient history etc.', 'interventionNames': ['Drug: cephalosporins', 'Drug: Fluoroquinolones', 'Drug: Clindamycin', 'Drug: Ampicillin/Gentamicin']}], 'interventions': [{'name': 'cephalosporins', 'type': 'DRUG', 'otherNames': ['ancef'], 'description': 'Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed', 'armGroupLabels': ['Antibiotics for a 24 hour period', 'Continued antibiotics']}, {'name': 'Fluoroquinolones', 'type': 'DRUG', 'otherNames': ['ciprofloxacin'], 'description': 'If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance', 'armGroupLabels': ['Antibiotics for a 24 hour period', 'Continued antibiotics']}, {'name': 'Clindamycin', 'type': 'DRUG', 'otherNames': ['Lincosamides'], 'description': 'If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.', 'armGroupLabels': ['Antibiotics for a 24 hour period', 'Continued antibiotics']}, {'name': 'Ampicillin/Gentamicin', 'type': 'DRUG', 'otherNames': ['Penicillinase-sensitive penicillin\\Aminoglycoside'], 'description': '5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin', 'armGroupLabels': ['Antibiotics for a 24 hour period', 'Continued antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Zeph Okeke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}