NCT05353634

Metagenomic Sequencing in Clinical Infectious Diseases

Completed Last updated 29 April 2022

What this trial tests

trial testing Effects of mNGS on infected patients in Bacterial Infections and Mycoses in 2,022,097 participants. Completed in 20 April 2022.

Timeline

10 June 2020

Primary endpoint
16 October 2021

20 April 2022

Quick facts

Lead sponsor	Liaocheng People's Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,022,097
Start date	10 June 2020
Primary completion	16 October 2021
Estimated completion	20 April 2022
Sites	1 location across China

Drugs / interventions tested

• Effects of mNGS on infected patients

Conditions studied

• Bacterial Infections and Mycoses — all drugs for Bacterial Infections and Mycoses →

Sponsor

Liaocheng People's Hospital

Who can join

Eligibility, any sex, with Bacterial Infections and Mycoses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.