Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China

Cirrhosis Clinical Trial

— SONIC  

Official title:

Prospective, Non-interventional, Multicenter Observational Study of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676777
• Other study ID #: SONIC
• Status: Recruiting
• Start date: November 7, 2018
• Est. completion date: February 2020

Study information

• Verified date: November 2019
• Source: Ruijin Hospital
• Contact: Qing Xie, M.D., Ph.D.
• Phone: 0086 13651804273
• Email: xieqingrjh[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1232
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Inpatient with cirrhosis as confirmed either by the histological scoring system, imaging technique (abdominal Ultrasound, CT or MRI), endoscopic findings or a combination of biochemical and clinical manifestation.

• Admitted for at least one of the following reasons:

1. Bacterial infection/fungal infection

2. Overt Ascites (Grade II-III)

3. Gastrointestinal bleeding

4. Hepatic encephalopathy

5. Jaundice (Total bilirubin =5 mg/dL) with coagulation dysfunction (INR =1.5)

Exclusion Criteria:

• 1. Age below 16 or over 80 years

• 2. Lactation/ Pregnancy women

• 3. HIV infection

• 4. Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugular intrahepatic portosystemic shunting, liver biopsy) or re-examination or multidisciplinary consultation)

• 5. Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies

• 6. Previous liver transplantation

• 7. With previously known severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease; severe chronic pulmonary disease, psychiatric disorders)

• 8. Taking immunosuppressive or anticoagulation drugs for the treatment of extra-hepatic disease.

• 9. Patient' s refusal to participation

• 10. Failure to provide prior informed consent or with documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Infection
• Liver Cirrhosis
• Mycoses

Locations

Country	Name	City	State
China	Department of Critical Care Medicine of Liver Disease, Beijing You'an Hospital, Capital Medical University	Beijing	Beijing
China	Department of Liver Diseases, The Third People's Hospital of Changzhou	Changzhou	Jiangsu
China	Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Department of severe Liver Diseases, Fuzhou Municipal Infectious Disease Hospital, Mengchao Hepatobiliary Hospital of Fujian Medical University,	Fuzhou	Fujian
China	The Third People's Hospital of Guilin	Guilin	Guangxi
China	Department of Infectious Diseases, Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The first Hospital of Jiaxing	Jiaxing	Zhejiang
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 First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Ningbo no.2 Hospital	Ningbo	Zhejiang
China	Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai
China	Department of Hepatology and Infection, Tongren Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Department of Infectious Diseases, Third Affiliated Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Department of Infectious Diseases, the Fifth People's Hospital of Suzhou	Suzhou	Jiangsu
China	First Affiliated Hospital, Wenzhou Medical University	Wenzhou	Zhejiang
China	The Fifth People's Hospital of Wuxi, Affiliated to Jiangnan University	Wuxi	Jiangsu
China	Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University.	Xi'an	Shanxi
China	Xiamen Hospital of Traditional Chinese Medicine	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day transplantation-free Survival	Survival at 28-day follow-up without liver transplantation	From admission to 28-day post-admission
Secondary	Characteristics of bacterial/fungal infection including the prevalence of infection, the source of acquisition, type of infection, multidrug resistance rate, antibiotic treatment efficiency and efficacy in relation to disease course and outcome	Characteristics of bacterial/fungal infection including the prevalence of infection, the source of acquisition, type of infection, multidrug resistance rate, antibiotic treatment efficiency and efficacy in relation to disease course and outcome	From admission to discharge, an average of 28-day
Secondary	Association between bacterial/fungal infection between other complications of cirrhosis?organ failure?AKI or ACLF.	Association between bacterial/fungal infection between other complications of cirrhosis?organ failure?AKI or ACLF.	From admission to discharge, an average of 28-day
Secondary	Difference in type of organ failure between bacterial/fungal infection and other precipitating events.	Difference in type of organ failure between bacterial/fungal infection and other precipitating events.	From admission to discharge, an average of 28-day
Secondary	ACLF and each sub-type organ failure development at 28-day	ACLF defined as per EASL CLIF-C or NACSELD definition Organ failure defined as per CLIF-C OF criteria, including Liver, coagulation, kidney, brain, respiratory and circulatory.	From admission to discharge, an average of 28-day
Secondary	Transplantation-free Survival at 90-day	Survival at 90-day follow-up without liver transplantation	From admission to 90 day post-admission
Secondary	Overall survival at 28-?90-day	Overall survival at 28-?90-day	From admission to 90 day post-admission
Secondary	Readmission and further decompensations rate at 90-day post discharge	Readmission and further decompensations rate at 90-day post discharge	From admission to 90 day post-discharge