Metagenomic Sequencing in Clinical Infectious Diseases

NCT05353634 | Completed

• 1 other identifier: 2022097
• Study Type: observational
• Target: 2,022,097
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections and Mycoses

Keywords

clinical metagenomics; infection diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Infected patients with mNGS

If the patient is suspected of infection, mNGS is performed for testing.

Diagnostic Test: Effects of mNGS on infected patients

Infected patients without mNGS

The patient is suspected of being infected, and no mNGS test was performed, only other tests were performed.

Diagnostic Test: Effects of mNGS on infected patients

Interventions

Effects of mNGS on infected patients DIAGNOSTIC_TEST

The impact of mNGS on infected patients, including diagnostic value, drug selection, treatment prognosis, economic burden, etc.

Infected patients with mNGS; Infected patients without mNGS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Interruption of patient treatment process and incomplete information

Sponsors & Collaborators

• Liaocheng People's Hospital: lead

Study Sites (1)

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

Location

MeSH Terms

Conditions

Bacterial Infections and Mycoses

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Shengjun Ma, Dr.

  Liaocheng People's Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 29, 2022
• Study Start: June 10, 2020
• Primary Completion: October 16, 2021
• Study Completion: April 20, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)