Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in

Status Completed

Clinical Trial 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

Clinical Trial 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 An unpublished French study from 2000 revealed low vaccination rates: 34% for pneumococcus, 55% for influenza, 32 to 42% for the hepatitis B virus and 20 to 38% for the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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04939350
Study type	Observational
Source	Centre Hospitalier Sud Francilien
Contact
Status	Completed
Phase
Start date	September 27, 2021
Completion date	December 27, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01884415` - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis	Phase 3
Recruiting	`NCT05014594` - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT	Phase 2
Not yet recruiting	`NCT03631147` - The Effect of Rifaximin on Portal Vein Thrombosis	N/A
Completed	`NCT02528760` - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis	N/A
Recruiting	`NCT05484206` - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434	Phase 1
Not yet recruiting	`NCT05538546` - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting	`NCT04053231` - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting	`NCT02983968` - Use of the French Healthcare Insurance Database
Completed	`NCT02705534` - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1	Phase 3
Completed	`NCT02596880` - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics	Phase 3
Completed	`NCT02247414` - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection	Phase 4
Completed	`NCT02016196` - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS	Phase 3
Withdrawn	`NCT01956864` - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer	Phase 1
Completed	`NCT01362855` - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed	`NCT01447537` - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis	N/A
Completed	`NCT02113631` - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir	N/A
Active, not recruiting	`NCT01205074` - ¹³C-Methacetin Breath Test (MBT) Methodology Study	Phase 2/Phase 3
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01231828` - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.	N/A
Terminated	`NCT00375011` - Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021 — VACCIR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms