Clinical trial NCT05353634: Metagenomic Sequencing in Clinical Infectious Diseases
Official title: Research on the Diagnostic Application of Metagenomic Sequencing in Clinical Infectious Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections and Mycoses
Keywords: clinical metagenomics; infection diseases
Lead sponsor: Liaocheng People's Hospital
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 2022097
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the enrolled patients have received mNGS testing in clinical practice. Clinical data were rigorously evaluated and summarized, patients' data were compiled until death or hospital discharge.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Interruption of patient treatment process and incomplete information

Primary outcomes:
measure: Receiver operating characteristic (ROC) curves evaluate the performance of mNGS and traditional microbiological testing
timeFrame: From admission to discharge, 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
Study officials:
affiliation: Liaocheng People's Hospital
name: Shengjun Ma, Dr.
role: STUDY_CHAIR
References: