Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT04152369
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008096', 'term': 'Lithotripsy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).', 'timeFrame': '7 days', 'description': 'To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures. This conclusion will be based on measurements of CRP \\[mg/dl\\] as follows: one day prior to procedure, one day post and 7 days after the procedure. The data will be statistically analyzed.'}, {'measure': 'Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).', 'timeFrame': '7 days', 'description': 'To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures. This conclusion will be based on measurements of WBC level \\[x 10\\^9/l\\] as follows: one day prior to procedure, one day post and 7 days after the procedure. The data will be statistically analyzed.'}, {'measure': 'Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).', 'timeFrame': '7 days', 'description': 'To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures. This conclusion will be based on measurements of levels of prokalcytonin \\[ng/ml\\] as follows: one day prior to procedure, one day post and 7 days after the procedure. The data will be statistically analyzed.'}, {'measure': 'Safety and efficacy of perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures and ESWL (Extracorporeal Shock Wave Lithotripsy).', 'timeFrame': '7 days', 'description': 'To determine if a 1-day perioperative antibiotic prophylaxis is as safe and effective as 3-day perioperative antibiotic prophylaxis in patients with Enterobacteriacae ESBL+ urinary tract colonization undergoing endourological procedures. This conclusion will be based on measurements of body temperature \\[Celsius\\] as follows: one day prior to procedure, one day post and 7 days after the procedure. The data will be statistically analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESBL+', 'Antimicrobial prophylaxis'], 'conditions': ['Antimicrobial Prophylaxis', 'Asymptomatic Bacteriuria']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine optimal safe duration of antibiotic prophylaxis in patients undergoing endourological procedures and ESWL, presenting with asymptomatic bacteriuria caused by multi-drug resistant bacterial strains. In this study we compare safety and efficacy of a one-day vs. three-day AMP (Antimicrobial Prophylaxis) in the above mentioned group of patients.', 'detailedDescription': 'Patients with positive urine culture with Enterobacteriacae ESBL + resistance mechanism upon admission for endourological procedure or ESWL were subjected to body temperature measurement and laboratory tests: smear from the anus towards the presence of alarm pathogens, urinalysis, control urine culture, blood count, CRP (C-reactive protein), procalcitonin (PCT). After confirming the occurrence of asymptomatic bacteriuria, the patients were randomized to two groups - a one-day and three-day period lasting perioperative antibiotic prophylaxis. In both groups on the following day after the procedure (24 hours after the procedure) and after 7 days after the procedure, laboratory tests and body temperature measurements were performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ESBL+ asymptomatic bacteriuria\n* assigned for endourological procedure\n* normal CRP, PCT and WBC\n* patient's consent\n\nExclusion Criteria:\n\n* urinary tract infection\n* raised levels of CRP, PCT, WBC\n* fever\n* non ESBL+ bacteriuria\n* inability to consent"}, 'identificationModule': {'nctId': 'NCT04152369', 'acronym': 'ESBL', 'briefTitle': '"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': '"Comparison of the Effectiveness of 24-hour and 72-hour Peri-procedural Antimicrobial Prophylaxis in Patients Undergoing Endourological Procedures and ESWL Presenting With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"', 'orgStudyIdInfo': {'id': '0000000495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '24 hour prophylaxis', 'description': 'In this group patients received a AMP for the day of the procedure', 'interventionNames': ['Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '72 hour prophylaxis', 'description': 'In this group patients received a AMP one day prior, on the day of the procedure and the following day.', 'interventionNames': ['Procedure: Anti-microbial prophylaxis for an endourological procedure or ESWL']}], 'interventions': [{'name': 'Anti-microbial prophylaxis for an endourological procedure or ESWL', 'type': 'PROCEDURE', 'description': 'anti-microbial prophylaxis according to urine culture results', 'armGroupLabels': ['24 hour prophylaxis', '72 hour prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Marcin A Radko, MD', 'role': 'CONTACT', 'email': 'mradko@wim.mil.pl', 'phone': '+48 603768924'}, {'name': 'Malgorzata Kowanska', 'role': 'CONTACT', 'email': 'mkowanska@wim.mil.pl'}], 'facility': 'Military Institue of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Marcin A Radko, MD', 'role': 'CONTACT', 'email': 'mradko@wim.mil.pl', 'phone': '+48603768924'}], 'overallOfficials': [{'name': 'Marcin A Radko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}, {'name': 'Henryk Zieliński, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Military Institute of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marcin Radko', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}