Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
- Conditions
- Cirrhosis
- Registration Number
- NCT04939350
- Lead Sponsor
- Centre Hospitalier Sud Francilien
- Brief Summary
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
- Detailed Description
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.
Limiting 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.
There 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 An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the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.
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 742
- adult patient
- histologically proven or asserted cirrhosis on a combination of clinical, biological, endoscopic and radiological criteria
- follow-up of cirrhosis > 6 months
- subject informed of the study and not having objected to it.
- immunosuppression not related to liver disease: HIV, variable common immune deficiency, chemotherapy, anatomical splenectomy, immunosuppressive treatments for non-hepatic disease
- vaccine contraindication.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method percentage fully immunization coverage Day 0 percentage of patients fully vaccinated against polio DT, seasonal influenza, HAV, HBV, pneumococcal and COVID19 in our sample
- Secondary Outcome Measures
Name Time Method percentage HBV immunization coverage Day 0 Percentages of vaccination against HBV
percentage DTpolio immunization coverage Day 0 Percentage of vaccination against DTPolio
percentage HAV immunization coverage Day 0 Percentage of vaccination against HAV
percentage Pneumococcal immunization coverage Day 0 Percentages of vaccination against pneumococcaL
percentage Influenza virus immunization coverage Day 0 Percentage of vaccination against seasonal influenza
percentage COVID immunization coverage Day 0 Percentage of vaccination against COVID19
Trial Locations
- Locations (1)
Centre Hospitalier Sud Francilien
🇫🇷Corbeil-essonnes Cedex, France