Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-28 @ 2:37 PM
Study NCT ID:
NCT06511492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1289}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of rectal colonization by MDROs in patients with cirrhosis', 'timeFrame': '90 days', 'description': 'The prevalence of rectal colonization by MDROs in patients with cirrhosis during hospitalization'}, {'measure': 'The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers', 'timeFrame': '90 days', 'description': 'The onset of infection with MDR bacteria in cirrhosis patients with asymptomatic carriers and describe the risk of colonization both to other patients and to themselves.'}], 'secondaryOutcomes': [{'measure': 'The risk factors associated with rectal colonization by MDROs in patients with cirrhosis.', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cirrhosis, Liver', 'Rectal Colonization', 'Multidrug Resistance Organisms']}, 'descriptionModule': {'briefSummary': 'Antimicrobial resistance has emerged as a global threat, and multidrug resistance organisms (MDROs) form one of the foremost challenges in the setting of decompensated cirrhosis. In a worldwide study, a high prevalence (34%) of infection with MDR bacteria in patients with cirrhosis and associated with higher in-hospital mortality.\n\nPrevious study indicated that the pattern of colonized bacteria in heterogeneous and the colonization by MDROs is associated with increased risk of infection. Effort should be made to reduce the spread of MDR bacteria and improvement in prognosis in patents with cirrhosis. Currently, strategies suggested to prevent the spread of MDROs in cirrhosis, including rapid microbiological tests, new first-line antibiotic schedules, infection control practices and epidemiological surveillance.\n\nThus, for the aims of this cohort study are as following. Firstly, to characterize the burden, dynamics and risk factors associated with rectal colonization by MDROs in patients with cirrhosis. Secondly, to completely characterize the risk that asymptomatic carriers of MDROs, both to other patients and to themselves via collecting detailed longitudinal sampling and high-resolution typing. Lastly, to generate evidence for future policymaking for individualized antimicrobial decision rather than umbrella guidelines since the variance in the bacteriological profiles in different settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhosis patients with acute decompensation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>18 years old;\n2. Inpatients;\n3. Cirrhosis patients with acute decompensation;\n\nExclusion Criteria:\n\n1. Patients decline any swab type;\n2. Patients had liver resection or other organ transplantation;\n3. Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;\n4. Hospital stays \\<48 hours;\n5. Not suitable to participate in this study judging by researchers;'}, 'identificationModule': {'nctId': 'NCT06511492', 'briefTitle': 'Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Longitudinal Surveillance of Rectal Colonization and Transmission by Resistant Bacteria in Acutely Decompensated Cirrhosis: a Cohort Study', 'orgStudyIdInfo': {'id': 'NFEC-2023-469'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention in this study', 'type': 'OTHER', 'description': 'No intervention in this study'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}