Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-21 @ 3:53 PM
Study NCT ID:
NCT02575495
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2015-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001437', 'term': 'Bacteriuria'}, {'id': 'D058345', 'term': 'Asymptomatic Infections'}], 'ancestors': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D058070', 'term': 'Asymptomatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2015-10-08', 'studyFirstSubmitQcDate': '2015-10-11', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate', 'timeFrame': '1 month', 'description': 'Composite end point at 1 month after discontinuing antibiotics'}], 'secondaryOutcomes': [{'measure': 'Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and Mortality rate', 'timeFrame': '0.5 months', 'description': 'Composite end point at 0.5 months after discontinuing antibiotics'}, {'measure': 'Composite end point of Symptomatic urinary tract infection, Sepsis, Graft function and', 'timeFrame': '3 months', 'description': 'Composite end point at 3 months after discontinuing antibiotics'}, {'measure': 'duration of hospital stay', 'timeFrame': '30 days since randomization', 'description': 'duration of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'Bacteriuria', 'Asymptomatic Infections']}, 'descriptionModule': {'briefSummary': 'The major hypothesis to be tested is that there was no difference in the clinical outcome between 7(short-course) and 14(traditional-course) days of antibiotic treatment for asymptomatic bacteriuria early after kidney transplantation.', 'detailedDescription': 'Introduction: Treatment of asymptomatic bacteriuria is a common practice in renal transplant centers leading to prolong exposure of antimicrobial agents with long hospital length of stay. The duration of antibiotics treatment in this condition have never been proposed.\n\nObjective: To evaluate the proper duration of antibiotic treatment for asymptomatic bacteriuria early (less than 1 month) after kidney transplantation\n\nMethod: This is a prospective, randomized, open labeled, single center study using intention to treat analysis. Patients will be identified and after informed consent is obtained, will be randomized to receive 7 or 14 days course of antibiotics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First kidney transplantation\n* Asymptomatic bacteriuria\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Re-transplantation or combined organ transplantation\n* History of abnormal structure or function in native kidney, ureter and bladder system\n* Kidney transplant recipients with history of recurrent urinary tract infection or incomplete course of urinary tract infection treatment before transplantation\n* Hemodynamic unstable\n* Urosepsis or other serious infectious complications(eg. symptomatic urinary tract infection/graft pyelonephritis, surgical site infection, infected urinoma/ hospital acquired pneumonia that mandates antibiotic therapy)\n* Surgical complication (eg. anastomosis leakage, collection, ureteric stricture)'}, 'identificationModule': {'nctId': 'NCT02575495', 'briefTitle': 'A Randomized Control Trial of Antibiotic Treatment Duration For Asymptomatic Bacteriuria After Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Pilot Randomized Control Study of Shortening Antibiotic Treatment Duration For Asymptomatic Bacteriuria Within A Month After Kidney Transplantation', 'orgStudyIdInfo': {'id': 'EC_580278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7 days course of antibiotic treatment', 'description': 'To assign the 7 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture', 'interventionNames': ['Drug: 7 days course of antibiotic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': '14 days course of antibiotic treatment', 'description': 'To assign the 14 days course of antibiotic treatment, start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture', 'interventionNames': ['Drug: 14 days course of antibiotic treatment']}], 'interventions': [{'name': '7 days course of antibiotic treatment', 'type': 'DRUG', 'otherNames': ['short-course antibiotic treatment'], 'description': 'start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days', 'armGroupLabels': ['7 days course of antibiotic treatment']}, {'name': '14 days course of antibiotic treatment', 'type': 'DRUG', 'otherNames': ['traditional-course antibiotic treatment'], 'description': 'start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days', 'armGroupLabels': ['14 days course of antibiotic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Pattraporn Ponglorpisit', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'Pattraporn Ponglorpisit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}