Metagenomic Sequencing in Clinical Infectious Diseases

Bacterial Infections and Mycoses Clinical Trial

Official title:

Research on the Diagnostic Application of Metagenomic Sequencing in Clinical Infectious Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353634
• Other study ID #: 2022097
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: April 20, 2022

Study information

• Verified date: April 2022
• Source: Liaocheng People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Progress in the diagnosis of infectious pathogens depends on the development of effective methods and the discovery of suitable biomarkers. There are several kinds of methods that have been used in diagnosis of various pathogens, such as microscopic examination, culture, serologic diagnosis or molecular approaches, etc. However, these methods have similar limitations, that is, the single detection of reagents. More importantly, physicians seldom consider infections with rare pathogens. Recently developed metagenomic next-generation sequencing (mNGS) has the capability to overcome limitations of traditional diagnostic tests. This new technology could identify all pathogens directly from sample with a single run in a hypothesis-free and culture-independent manner. Studies have shown that mNGS is more sensitive than traditional culture method in clinical conditions such as blood stream, respiratory and general infections. More importantly, due to unbiased sampling, mNGS is theoretically able to identify not only known but also unexpected pathogens or even discovery novel organisms. It should be noted that mNGS also has some limitations such as human genome contamination and possibly environmental microbial contamination. The vast majority of reads in mNGS are derived from human host. This would impede the overall analytical sensitivity of mNGS for pathogen detection. Host depletion methods or targeted sequencing may help to partially mitigate this disadvantage. As mNGS could not, by itself, define whether the detected microbe is the causative pathogen or environmental microorganism, a multidisciplinary discussion by clinicians, microbiologists as well as the lab technicians is required to interpret the result.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2022097
• Est. completion date: April 20, 2022
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All the patients have received mNGS testing in clinical practice.

Exclusion Criteria:

• Interruption of patient treatment process and incomplete information

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterial Infections and Mycoses
• Communicable Diseases
• Infections
• Mycoses

Intervention

Diagnostic Test:
• Effects of mNGS on infected patients
The impact of mNGS on infected patients, including diagnostic value, drug selection, treatment prognosis, economic burden, etc.

Locations

Country	Name	City	State
China	Liaocheng People's Hospital	Liaocheng	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Liaocheng People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receiver operating characteristic (ROC) curves evaluate the performance of mNGS and traditional microbiological testing	Receiver operating characteristic (ROC) curves were used to evaluate the performance of the logarithm of reads per kilobase per million mapped reads [lg(RPKM)], genomic coverage, and relative abundance of the organism in predicting the true-positive pathogenic bacteria. Clinical data were rigorously evaluated and summarized to identify promising clinical indices and limitations of the mNGS-based test.	From admission to discharge, 3 weeks