Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT02777632
Status:
COMPLETED
Last Update Posted:
2017-02-06
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistant Bacterial Infections in the Early Post LDLT Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the types of early bacterial infections following LDLT, recurrent and resistant infections all were confirmed by cultures.', 'timeFrame': 'Within the first 90 days after the operation', 'description': 'Bile, abdominal drains, blood stream infection, urinary tract infection or chest infection.'}, {'measure': 'Assessment of risk factors for occurrence of recurrent bacterial infections', 'timeFrame': 'The first 3 months following LDLT', 'description': 'Independent risk factors for infections'}]}, 'conditionsModule': {'conditions': ['Transplantation Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this work was to study the incidence, types, risk factors and causative organisms of bacterial infections in HCV Egyptian patients following Liver Transplantation. Moreover, to identify the emerging resistant strains and their proper antimicrobial therapy', 'detailedDescription': 'This prospective descriptive study has been done at Tropical Medicine department in the period between January 2014 to November 2015.\n\nAfter the approval of the scientific and ethical committee of Ain Shams University Hospital, Patients with HCV positive end stage liver disease (ESLD) eligible for liver transplantation Ain Shams Center for Organ Transplant (ASCOT); Ain Shams University, (fulfilling the inclusion criteria) were included in the current study. Forty five patients were recruited and each one was followed-up during a period of 3 months following transplantation.\n\nIncluded patients were divided into 2 groups:\n\nGroup 1 included patients who had a postoperative single episode of infection. Group 2 included those patients who had more than 1 episode of postoperative bacterial infection whom were further evaluated for the presence of emerging strains and/or antibiotic resistance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HCV patients who underwent living donor liver transplantation at Ain Shams Center for Organ Transplantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Egyptian nationality.\n* Accepting participation in the current study and signing a written consent form\n* Age between 18-60 Years, including males and females.\n\nExclusion Criteria:\n\n* Patients who refused to be enrolled in the study.\n* Patients with other etiologies for end-stage liver disease (HBV, PBC…)\n* Patients with preoperative infections, infections within 48 h after transplantation or early post-operative death'}, 'identificationModule': {'nctId': 'NCT02777632', 'briefTitle': 'Resistant Bacterial Infections in the Early Post LDLT Period', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Resistant Bacterial Infections in the Early Post LDLT Period', 'orgStudyIdInfo': {'id': '2652010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCV patients following living donor liver transplantation', 'description': 'single infection episode group', 'interventionNames': ['Procedure: Living donor liver transplantation']}, {'label': 'patients following living donor liver transplantation', 'description': 'recurrent Infections episode group', 'interventionNames': ['Procedure: Living donor liver transplantation']}], 'interventions': [{'name': 'Living donor liver transplantation', 'type': 'PROCEDURE', 'armGroupLabels': ['HCV patients following living donor liver transplantation', 'patients following living donor liver transplantation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yasmine M Massoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Tropical medicine', 'investigatorFullName': 'Yasmine Mahmoud Aly Massoud', 'investigatorAffiliation': 'Ain Shams University'}}}}