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Prospective, Non-interventional, Multicenter Observational Study of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
This is a national, investigator-initiated, multicenter, prospective, observational, web-based registry in hospitalized patients with cirrhosis across China. The overarching aim of this study is to investigate the epidemiology and clinical impact of bacterial/fungal infections in hospitalized patients with liver cirrhosis in China within the collaborative network. We also aimed to build up the national prospective cohort of hospitalized cirrhosis in China to stand in the future for the backbone of various research programs focused on infection, other complications of cirrhosis, organ failure, the ACLF syndrome, end-stage liver disease and beyond.
Patients with cirrhosis are prone to infections due to the abnormal bacterial translocation and immune dysfunction. Infections are more common when these patients are admitted into the hospital. Infections are life-threatening complications of cirrhosis which can precipitate hepatic encephalopathy, acute kidney injury, and the acute-on-chronic liver failure (ACLF) syndrome. The survival rate is significantly decreased once infections set in, especially when the first-line empirical antibiotic therapy is insufficient or inappropriate. Moreover, the prevalence of multi-drug-resistant organism (MDRO) is naturally increasing across the world due to the overuse of antibiotics. Patients with cirrhosis, especially those at the decompensated stage are at high risk of developing MDRO due to recurrent hospitalizations and repeatedly exposed to antibiotics either for treatment or prophylactic purposes. Empiric antibiotic therapy could be very difficult without understanding the profile of antibiotic resistance and could be varied significantly among different areas. The issue of infection in patients with cirrhosis has been recently highlighted by International Club of Ascites with its "GLOBAL" study (ILC2018, GS-001) showing that the global prevalence of MDRO across the world was 34% (95% CI=31-37%). The prevalence of MDRO varies across the world with the highest in India followed by South America and other Asian countries. The source of acquisition (Community acquire, health-care related or nosocomial origin), site of infection (Spontaneous bacterial peritonitis, urinary tract, blood, respiratory tract, etc.) and category of the organism (Gram negative or positive) had an influence on the prevalence of MDRO and response to empirical antibiotic treatment. The results highlight the need to develop different empirical antibiotic strategies across different continents and countries, although China was not included in this study. Epidemiology data and investigation on the role of bacterial/fungal infection in patients with cirrhosis from China is therefore urgently needed. The overarching aim of this study is to investigate the epidemiology and clinical impact of bacterial/fungal infections in hospitalized patients with liver cirrhosis in China within the collaborative network. We also aimed to build up the national prospective cohort of hospitalized cirrhosis in China to stand in the future for the backbone of various research programs focused on infection, other complications of cirrhosis, organ failure, the ACLF syndrome, end-stage liver disease and beyond.
Age
16 - 80 years
Sex
ALL
Healthy Volunteers
No
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Department of Critical Care Medicine of Liver Disease, Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Department of severe Liver Diseases, Fuzhou Municipal Infectious Disease Hospital, Mengchao Hepatobiliary Hospital of Fujian Medical University,
Fuzhou, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Department of Infectious Disease, The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First People's Hospital of Lanzhou City
Lanzhou, Gansu, China
The Third People's Hospital of Guilin
Guilin, Guangxi, China
Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Department of Infectious Diseases, Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Start Date
November 7, 2018
Primary Completion Date
December 1, 2019
Completion Date
February 1, 2020
Last Updated
November 19, 2019
1,232
ESTIMATED participants
Lead Sponsor
Ruijin Hospital
NCT05597488
NCT06932783
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06306963