Metagenomic Sequencing in Clinical Infectious Diseases

NCT ID: NCT05353634

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2022097 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2022-04-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

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

Liaocheng People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengjun Ma, Dr.

Role: STUDY_CHAIR

Liaocheng People's Hospital

Locations

Liaocheng People's Hospital

Liaocheng, Shandong, China

Countries

China

Other Identifiers

2022097

Identifier Type: -

Identifier Source: org_study_id