Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-05 @ 5:13 PM
Study NCT ID:
NCT03919032
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bacterial Infections in Patients with Cirrhosis in Argentina: Clinical and Microbiological Characteristics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the prevalence of infections caused by multi-resistant microorganisms in patients with cirrhosis', 'timeFrame': 'at the moment of the diagnosis of the bacerial infection'}], 'secondaryOutcomes': [{'measure': 'To evaluate variables associated with infections caused by multi-resistant microorganisms in patients with cirrhosis', 'timeFrame': 'at the moment of the diagnosis of the bacerial infection'}, {'measure': 'To evaluate the effect of infections caused by multi-resistant microorganisms on the in-hospital survival of patients with cirrhosis', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bacterial Infections', 'Cirrhosis', 'Resistant Infection', 'Morality']}, 'referencesModule': {'references': [{'pmid': '37030570', 'type': 'DERIVED', 'citation': 'Vazquez C, Gutierrez-Acevedo MN, Barbero S, Notari LDC, Agozino M, Fernandez JL, Anders MM, Grigera NL, Antinucci F, Orozco-Ganem ONF, Murga MD, Perez MD, Palazzo AG, Rejtman LM, Duarte IG, Vorobioff JD, Trevizan V, Bulaty S, Bessone F, Valverde M, Elizondo M, Borzi SM, Stieben TE, Masola AC, Ferretti SE, Arufe D, Demirdjian E, Raffa MP, Peralta M, Fainboim HA, Vazquez CE, Ruiz PM, Martinez JE, Heffner LA, Odzak A, Dirchwolf M, Smud A, Mendizabal M, Calzetta PA, Martinez A, Tomatis J, Bruno A, Ramos A, Pages J, Tevez S, Gadano AC, Giunta DH, Marciano S. Clinical and microbiological characteristics of bacterial infections in patients with cirrhosis. A prospective cohort study from Argentina and Uruguay. Ann Hepatol. 2023 Jul-Aug;28(4):101097. doi: 10.1016/j.aohep.2023.101097. Epub 2023 Apr 6.'}, {'pmid': '36820931', 'type': 'DERIVED', 'citation': 'Marciano S, Gutierrez-Acevedo MN, Barbero S, Del C Notari L, Agozino M, Fernandez JL, Anders MM, Grigera N, Antinucci F, Orozco Ganem OF, Murga MD, Perez D, Palazzo A, Martinez Rejtman L, Duarte IG, Vorobioff J, Trevizan V, Bulaty S, Bessone F, Valverde M, Elizondo M, Bosia JD, Borzi SM, Stieben TE, Masola A, Ferretti SE, Arufe D, Demirdjian E, Raffa MP, Peralta M, Fainboim HA, Vazquez CE, Ruiz P, Martinez JE, Heffner LA, Odzak A, Dirchwolf M, Smud A, Mendizabal M, Bellizzi C, Martinez A, Tomatis J, Bruno A, Ramos A, Pages J, Tevez S, Gadano AC, Giunta DH. Norfloxacin prophylaxis effect on multidrug resistance in patients with cirrhosis and bacterial infections. Eur J Clin Microbiol Infect Dis. 2023 Apr;42(4):481-491. doi: 10.1007/s10096-023-04572-2. Epub 2023 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, there has been an increasing prevalence of bacterial infections caused by multiresistant and extremely resistant organisms in patients with cirrhosis. These infections are associated with a worse prognosis, generate difficulties in the management of the patient during hospitalization and increase health costs.\n\nThe main objective of this project is to estimate the prevalence of infections by multiresistant bacteria in patients with cirrhosis. Additionally, the prevalence of other antibiotic resistance patterns and morbi-mortality in the study population will be evaluated.\n\nFor these purposes, a multicenter prospective cohort study will be carried out, including patients with cirrhosis who present bacterial infections at the time of admission, or during hospitalization.\n\nPerforming a study in Argentina on the clinical and microbiological characteristics of bacterial infections in patients with cirrhosis could be very useful to develop new strategies for prevention and treatment of this severe complication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 17 years with cirrhosis who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cirrhosis\n* Patients older than 17 years.\n* Patients who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized\n\nExclusion Criteria:\n\n• Refusal to participate in the informed consent process'}, 'identificationModule': {'nctId': 'NCT03919032', 'briefTitle': 'Bacterial Infections in Patients with Cirrhosis in Argentina: Clinical and Microbiological Characteristics', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Bacterial Infections in Patients with Cirrhosis in Argentina', 'orgStudyIdInfo': {'id': '3879'}}, 'armsInterventionsModule': {'interventions': [{'name': 'This is an observational study without intervention', 'type': 'OTHER', 'description': 'This is an observational study without intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1643', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sebastián Marciano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Hepatology , Principal Investigator', 'investigatorFullName': 'SEBASTIAN MARCIANO', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}