Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-02 @ 2:59 AM
Study NCT ID:
NCT04939350
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006506', 'term': 'Hepatitis A'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 742}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-15', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage fully immunization coverage', 'timeFrame': 'Day 0', 'description': 'percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample'}], 'secondaryOutcomes': [{'measure': 'percentage DTpolio immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentage of vaccination against DTPolio'}, {'measure': 'percentage HAV immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentage of vaccination against HAV'}, {'measure': 'percentage HBV immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentages of vaccination against HBV'}, {'measure': 'percentage Pneumococcal immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentages of vaccination against pneumococcaL'}, {'measure': 'percentage Influenza virus immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentage of vaccination against seasonal influenza'}, {'measure': 'percentage COVID immunization coverage', 'timeFrame': 'Day 0', 'description': 'Percentage of vaccination against COVID19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccinal coverage', 'vaccination', 'cirrhosis', 'cirrhotic', 'COVID', 'hepatitis B', 'hepatitis A', 'influenzae virus', 'pneumococcus', 'tetanus', 'poliomyelitis'], 'conditions': ['Cirrhosis']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the', 'detailedDescription': 'Cirrhosis is a serious liver disease very common in France, affecting nearly 200,000 people. These patients have an impaired immune response. They are, therefore, more frequently prone to bacterial, viral and fungal infections and these are more severe with high mortality. 30-50% of cirrhotics admitted to a hospital ward have sepsis, with pneumococcal bacterial infections being particularly severe. The risk of developing seasonal influenza is 5.7 times higher in cirrhotics with a risk of mortality multiplied by 169. COVID19 infection is responsible for a very high mortality (34%) in case of severe resuscitation form. Acute infections with hepatitis A (HAV) and B (HBV) viruses frequently lead to worsening liver failure decompensating to cirrhosis, and sometimes life-threatening fulminant hepatitis. Finally, chronic infection with the hepatitis B virus combined with another etiology of cirrhosis accelerates the course of liver disease and promotes the occurrence of hepatocellular carcinoma.\n\nLimiting the incidence of viral and bacterial infections in these patients is crucial. The High Authority of Health (HAS) published recommendations in 2007 advising patients with cirrhosis vaccinations against hepatitis A and B viruses, influenza and against bacterial pneumococcal infections, confirmed by the High Council of Public Health.\n\nThere are few data on vaccination coverage among cirrhotic patients. An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the hepatitis A virus. No recent studies have assessed the impact of the HAS recommendations.\n\nThe purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All cirrhotic patients followed for at least 6 months in consultation or hospitalization during the duration of the study in the general hospitals members of the ANGH participating in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient\n* histologically proven or asserted cirrhosis on a combination of clinical, biological, endoscopic and radiological criteria\n* follow-up of cirrhosis \\> 6 months\n* subject informed of the study and not having objected to it.\n\nExclusion Criteria:\n\n* immunosuppression not related to liver disease: HIV, variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease\n* vaccine contraindication.'}, 'identificationModule': {'nctId': 'NCT04939350', 'acronym': 'VACCIR', 'briefTitle': 'Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021 and in 2022.', 'orgStudyIdInfo': {'id': 'IDRCB 2021-A00343-38'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'patients will complete a vaccination questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}