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Metagenomic Sequencing in Clinical Infectious Diseases

NCT ID: NCT05353634

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2022097 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2022-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Infections and Mycoses

Keywords

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clinical metagenomics; infection diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Infected patients with mNGS

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

Effects of mNGS on infected patients

Intervention Type DIAGNOSTIC_TEST

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

Infected patients without mNGS

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

Effects of mNGS on infected patients

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Effects of mNGS on infected patients

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Interruption of patient treatment process and incomplete information
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liaocheng People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shengjun Ma, Dr.

Role: STUDY_CHAIR

Liaocheng People's Hospital

Locations

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Liaocheng People's Hospital

Liaocheng, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2022097

Identifier Type: -

Identifier Source: org_study_id