Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-29 @ 6:35 PM
Study NCT ID:
NCT01771432
Status:
UNKNOWN
Last Update Posted:
2015-06-22
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011704', 'term': 'Pyelonephritis'}], 'ancestors': [{'id': 'D009395', 'term': 'Nephritis, Interstitial'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D011702', 'term': 'Pyelitis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-19', 'studyFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infection by multiresistant microorganisms', 'timeFrame': 'First year after kydney transplantation'}], 'primaryOutcomes': [{'measure': 'To determine the incidence of pyelonephritis in both groups', 'timeFrame': 'First year after kidney transplantation'}], 'secondaryOutcomes': [{'measure': 'Renal function', 'timeFrame': 'First year after kydney transplantation'}, {'measure': 'Need for hospitalization', 'timeFrame': 'First year after kydney transplantation'}, {'measure': 'Incidence of graft loss', 'timeFrame': 'First year after kidney transplantation'}, {'measure': 'Mortality', 'timeFrame': 'First year after kidney transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asymptomatic Bacteriuria', 'Pyelonephritis']}, 'descriptionModule': {'briefSummary': 'Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.', 'detailedDescription': 'Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.\n\nMeasurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.\n\nPrimary end points: To determine in both groups: the incidence of pyelonephritis.\n\nSecondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who receive a transplant allograft during study period\n\nExclusion Criteria:\n\n* No acceptation of study'}, 'identificationModule': {'nctId': 'NCT01771432', 'acronym': 'BAC01', 'briefTitle': 'Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'FIS11-1540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic treatment', 'description': 'Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.', 'interventionNames': ['Drug: Antibiotic treatment']}, {'type': 'OTHER', 'label': 'No treatment', 'description': 'Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy', 'interventionNames': ['Other: No treatment']}], 'interventions': [{'name': 'Antibiotic treatment', 'type': 'DRUG', 'description': 'Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics', 'armGroupLabels': ['Antibiotic treatment']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy', 'armGroupLabels': ['No treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Núria Sabé Fernàndez', 'role': 'CONTACT', 'email': 'nfsabe@bellvitgehsopital.cat', 'phone': '+34932607625'}], 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'centralContacts': [{'name': 'Núria Sabé Fernàndez', 'role': 'CONTACT', 'email': 'nfsabe@bellvitgehospital.cat', 'phone': '+932607625'}], 'overallOfficials': [{'name': 'Núria Sabé Fernàndez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari de Bellvitge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Núria Sabé Fernàndez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Infectious Diseases Phisycian', 'investigatorFullName': 'Núria Sabé Fernàndez', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}