Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT03413293
Status:
UNKNOWN
Last Update Posted:
2018-05-18
First Post:
2018-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of nosocomial infection in patients with liver cirrhosis', 'timeFrame': 'baseline', 'description': 'nosocomial infection is one of predictors of bad outcome in liver cirrhosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nosocomial Infection']}, 'referencesModule': {'references': [{'pmid': '23907496', 'type': 'BACKGROUND', 'citation': 'Di Pasquale M, Esperatti M, Crisafulli E, Ferrer M, Bassi GL, Rinaudo M, Escorsell A, Fernandez J, Mas A, Blasi F, Torres A. Impact of chronic liver disease in intensive care unit acquired pneumonia: a prospective study. Intensive Care Med. 2013 Oct;39(10):1776-84. doi: 10.1007/s00134-013-3025-6. Epub 2013 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'Hospital acquired chest Infections are common complications in hospitalized cirrhotic patients. Infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia Intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures', 'detailedDescription': 'Aim of the work\n\n1. To estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients .\n2. To determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol.\n3. To define the impact of nosocomial chest infections on survival of our patients.\n4. To develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care .\n5. To motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient were known to have liver cirrhois and admitted at hospital secondary to any cause', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cirrhotic patients , decompensated , child pug score B or C ,may have Hepatocellular carcinoma , other comorbidities may present as (Diabetius mellitus , Hypertension , Heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission\n\nExclusion Criteria:\n\n* Patients have any chronic chest disease\n* Patients have severe immunosuppression (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and HIV-related disorders.'}, 'identificationModule': {'nctId': 'NCT03413293', 'briefTitle': 'Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients', 'orgStudyIdInfo': {'id': 'NBFCIIHCP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nosocomial infected cirrhotic patients', 'interventionNames': ['Diagnostic Test: Diagnosis of bacterial infections']}], 'interventions': [{'name': 'Diagnosis of bacterial infections', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cultures', 'armGroupLabels': ['Nosocomial infected cirrhotic patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nariman zaghluol bakhiet, postgraduate', 'role': 'CONTACT', 'email': 'narimandoctor@yahoo.com', 'phone': '01005546130'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'NZBakhiet', 'investigatorAffiliation': 'Assiut University'}}}}