CirrhosisSONICNCT03676777
Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
An observational study of Cirrhosis, run by Ruijin Hospital at 23 sites in China.
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… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Cirrhosis
- How many people
- 1,232 participants
- Where
- 23 sitesChina
- Study dates
- 7 Nov 2018to Feb 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients with cirrhosis evaluated in a dedicated and organized tertiary-care center (Liver Unit, Department of infectious diseases, Department of Gastroenterology, emergency department) across China.
Who may be able to join
- 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:
- Bacterial infection/fungal infection
- Overt Ascites (Grade II-III)
- Gastrointestinal bleeding
- Hepatic encephalopathy
- Jaundice (Total bilirubin ≥5 mg/dL) with coagulation dysfunction (INR ≥1.5)
Who cannot join
- 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
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- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Department of Critical Care Medicine of Liver Disease, Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality
Qinghua Meng, M.D., 0086 13601398756, wj5773@163.com
Qinghua Meng, M.D.,Ph.D.
- Recruiting
Department of Liver Diseases, The Third People's Hospital of Changzhou
Changzhou, Jiangsu
Longgen Liu, M.D., 0086 13606140932, ssewllg@163.com
Longgen Liu, M.D.
- Recruiting
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Peng Hu, M.D., Ph.D., 0086 13608338064, hp_cq@163.com
Peng Hu, M.D., Ph.D.
- Recruiting
Department of severe Liver Diseases, Fuzhou Municipal Infectious Disease Hospital, Mengchao Hepatobiliary Hospital of Fujian Medical University,
Fuzhou, Fujian
Minghua Lin, M.D., 0086 13860691603, lmh543@163.com
Minghua Lin, M.D.
- Recruiting
The Third People's Hospital of Guilin
Guilin, Guangxi
Yongchao Xian, M.D., 0086 18007736836, xianyongchao0901@163.com
Yongchao Xian, M.D.
- Recruiting
Department of Infectious Diseases, Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Hongying Pan, M.D., 0086 13958020498, hypanhz@139.com
Hongying Pan, M.D.
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Jiabin Li, M.D., Ph.D., lijiabin@ahmu.edu.cn
Jiabin Li, M.D., Ph.D.
- Recruiting
The first Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Xingsheng Xie, M.D.,Ph.D., 0573-82082937, jxxxs2010@163.com
Xingsheng Xie, M.D.,Ph.D.
- Recruiting
Department of Infectious Disease, The First Hospital of Lanzhou University
Lanzhou, Gansu
Xiaorong Mao, M.D., Ph.D., 0086 13919157938, mxr2013@126.com
Xiaorong Mao, M.D., Ph.D.
- Recruiting
The First People's Hospital of Lanzhou City
Lanzhou, Gansu
Yuerong Zhang, M.D., 1583332518@qq.com
Yuerong Zhang, M.D.
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Xiaoping Wu, M.D., Ph.D., 0086 13330122823, wuxiaoping2823@aliyun.com
Xiaoping Wu, M.D., Ph.D.
- Recruiting
Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Minghua Su, M.D., 0086 15807719292, smh9292@163.com
Minghua Su, M.D.
- Recruiting
Ningbo no.2 Hospital
Ningbo, Zhejiang
Yaoren Hu, M.D., 0086 13957881518, hu510@126.com
Huadong Yan, M.D., Ph.D., 0086 13586579885, huadongy588@163.com
- Recruiting
Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
Chenghai Liu, M.D.,Ph.D., 021-20256666, chenghailiu@hotmail.com
Chenghai Liu, M.D.,Ph.D.
- Recruiting
Department of Hepatology and Infection, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Qin Zhang, M.D.,Ph.D., 0086 13916348835
Qin Zhang, M.D.
- Recruiting
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Qing Xie, M.D., Ph.D., 0086 13651804273, xieqingrjh@163.com
Zhujun Cao, M.D., Ph.D., 0086 15216652990, estherlucifer@163.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Xiaoguang Dou, M.D.,Ph.D., 0086 18940251121, guang40@163.com
Xiaoguang Dou, M.D.,Ph.D.
- Recruiting
Department of Infectious Diseases, Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei
Caiyan Zhao, M.D., Ph.D., 0086 18533112898, zhaocy2005@163.com
Caiyan Zhao, M.D., Ph.D.
- Recruiting
Department of Infectious Diseases, the Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
Chuanwu Zhu, M.D., Ph.D., 0086 13606202525, zhuchw@126.com
Chuanwu Zhu, M.D., Ph.D.
- Recruiting
First Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang
Yongping Chen, M.D., chenyongping@wmu.edu.cn
Yongping Chen, M.D.
- Recruiting
The Fifth People's Hospital of Wuxi, Affiliated to Jiangnan University
Wuxi, Jiangsu
Lihua Huang, M.D., Ph.D., 0086 13601513551, huanglihua1964@sina.com
Lihua Huang, M.D., Ph.D.
- Recruiting
Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University.
Xi’an, Shanxi
Yingren Zhao, M.D., Ph.D., 0086 13509187086, zhaoyingren@mail.xjtu.edu.cn
Yingren Zhao, M.D., Ph.D.
- Recruiting
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian
Lijuan Ouyang, M.D., 0086 13799768907, oyl_1105@163.com
Lijuan Ouyang, M.D.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Cirrhosis
- Keywords
- Bacterial infection, Fungal infection, Cirrhosis, Multi-drug resistance, Antibiotic treatment, Clinical outcome, Organ failure, Acute-on-chronic liver failure, Decompensated cirrhosis, Complications of cirrhosis, Acute kidney injury
- Medical subject headings
- Fibrosis, Bacterial Infections, Mycoses, Acute-On-Chronic Liver Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infection | Patients admitted or developed bacterial/fungal infection while hospitalization | |
| Non-infection | Patients without bacterial/fungal infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day transplantation-free Survival
Survival at 28-day follow-up without liver transplantation
Measured: From admission to 28-day post-admission
Secondary outcomes (7)
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
Measured: From admission to discharge, an average of 28-day
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.
Measured: From admission to discharge, an average of 28-day
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.
Measured: From admission to discharge, an average of 28-day
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.
Measured: From admission to discharge, an average of 28-day
Transplantation-free Survival at 90-day
Survival at 90-day follow-up without liver transplantation
Measured: From admission to 90 day post-admission
Overall survival at 28-、90-day
Overall survival at 28-、90-day
Measured: From admission to 90 day post-admission
Readmission and further decompensations rate at 90-day post discharge
Readmission and further decompensations rate at 90-day post discharge
Measured: From admission to 90 day post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start7 Nov 2018
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,232 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing XIe, Ruijin Hospital
- Investigators
- Qing Xie, M.D., Ph.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676777
- Sponsor's protocol ID
- SONIC
- Acronym
- SONIC
- Status last verified
- Nov 2019
- First submitted
- 17 Sep 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Multicenter Observational Study of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
- ClinicalTrials.gov ID
- NCT03676777
- Acronym / sponsor ID
- SONIC / SONIC
- Conditions
- Cirrhosis
- Keywords
- Bacterial infection, Fungal infection, Cirrhosis, Multi-drug resistance, Antibiotic treatment, Clinical outcome, Organ failure, Acute-on-chronic liver failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,232 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection | – | –Patients admitted or developed bacterial/fungal infection while hospitalization |
| Non-infection | – | –Patients without bacterial/fungal infection |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients with cirrhosis evaluated in a dedicated and organized tertiary-care center (Liver Unit, Department of infectious diseases, Department of Gastroenterology, emergency department) across China.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day transplantation-free Survival
Time frame: From admission to 28-day post-admission
Survival at 28-day follow-up without liver transplantation
7 secondary outcomes
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
Time frame: From admission to discharge, an average of 28-day
Association between bacterial/fungal infection between other complications of cirrhosis、organ failure、AKI or ACLF.
Time frame: From admission to discharge, an average of 28-day
Difference in type of organ failure between bacterial/fungal infection and other precipitating events.
Time frame: From admission to discharge, an average of 28-day
ACLF and each sub-type organ failure development at 28-day
Time frame: From admission to discharge, an average of 28-day
Transplantation-free Survival at 90-day
Time frame: From admission to 90 day post-admission
Overall survival at 28-、90-day
Time frame: From admission to 90 day post-admission
Readmission and further decompensations rate at 90-day post discharge
Time frame: From admission to 90 day post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Xie, M.D., Ph.D. principal investigator
Ruijin Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Ruijin Hospital at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Xie, M.D., Ph.D. (0086 13651804273, xieqingrjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day transplantation-free Survival (time frame: From admission to 28-day post-admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.