Ascites Infection Clinical Trial
Official title:
Clinical Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases
Ascites is the most common complication of cirrhosis, and its development is associated with
substantially increased mortality. Ascites infection including spontaneous bacterial
peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared
complications of ascites. The EASL guidelines recommend that diagnostic criteria of SBP is
defined on the ascitic fluid polymorphonuclear leucocytes (PMN) count ≥250 cell/μl, with or
without ascites fluid positive culture. However, in clinical practice. Up to 30% of
hospitalized patients are considered as suspicious SBP, and treated as SBP without a
laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized
patients with ascites. Besides, fungal infection in ascites was aslo related to high
mortality in cirrhosis patients.
Thus, to diagnose ascites infection promptly is the key step to prevent the complication.
Since, the sensitivity of bacterial culture is limited even if ascites is directly injected
into blood culture bottles at the besides. New method to identified the pathogen is needed.
Here, we aim to use metagenomic next-generation sequencing(mNGS) to provide the first-ever
demonstration of precision medicine for the diagnosis of ascites infection in hospitalized
patients, with immediate impact on clinical care and patients outcomes. The method of mNGS is
undertaken by BGI Genomics Company which is a licensed clinical diagnostic laboratory in
China. In this multicenter and prospective clinical study, we are planning to detect ascites
sample by mNGS and compare the performance of mNGS and routine microbiological testing.
Ultimately, we aim to improve the diagnosis of ascites infection and improve patients'
outcomes.
The study is divided into 2 parts:
Firstly, the study will test 3 types of sample by means of mNGS, including ascites fluid,
peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and
specificity of NGS.
Secondly, the clinical validation of mNGS will be performed in multicenters for ascites
infection in cirrhosis patients. Furthermore, the study will collect the paired plasma sample
for NGS testing at the same time to evaluate the protential sources of microorganisms in
ascites.The aim of the study is to observe the performance of mNGS in ascites infection
diagosis and the protential clinical effect in cirrhsis patients.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04131751 -
Application of Clinical Metagenomics in the Diagnosis of Ascites
|
||
| Completed |
NCT05621005 -
Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients
|
Phase 2 | |
| Recruiting |
NCT05352152 -
Application of NGS in Ascites Infection
|