Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
NCT ID: NCT03676777
Last Updated: 2019-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1232 participants
OBSERVATIONAL
2018-11-07
2020-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Characteristics and Risk Factors for Invasive Fungal Infection With Acute-on-chronic Hepatitis B Liver Failure
NCT06190002
Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection
NCT06039696
Study on Prognosis of Acute-on-chronic Liver Failure Complicated by Bacterial or Fungal Infection
NCT06437067
Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure
NCT01872767
Systemic Inflammation in Liver Cirrhosis
NCT04850534
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Infection
Patients admitted or developed bacterial/fungal infection while hospitalization
No interventions assigned to this group
Non-infection
Patients without bacterial/fungal infection
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ruijin Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qing XIe
Head of the Department of Infectious diseases, Ruijin Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qing Xie, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Department of Liver Diseases, The Third People's Hospital of Changzhou
Changzhou, Jiangsu, China
Department of Infectious Diseases, the Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Fifth People's Hospital of Wuxi, Affiliated to Jiangnan University
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Department of Hepatology and Infection, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University.
Xi’an, Shanxi, China
Department of Infectious Diseases, Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The first Hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo no.2 Hospital
Ningbo, Zhejiang, China
First Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Qin Zhang, M.D.,Ph.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SONIC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.