Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

Guangzhou Medical University

Status: Enrolling

Conditions: AIDS; Sepsis, Neonatal; Pneumonia

Treatments: Diagnostic Test: Pathogen metagenomic next-generation sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT06145841

GZ8H-202322259s

Details and patient eligibility

About

This study aims to observe the effectiveness of clinical application in guiding anti-infection treatments in AIDS patients with severe pneumonia and/or sepsis using Metagenomic Next-Generation Sequencing-based technology in the real world

Full description

The study focuses on AIDS patients with severe pneumonia and/or sepsis, divided into groups based on whether metagenomic next-generation sequencing technology is used in the real world or not. The groups are the metagenomic next-generation sequencing group and the conventional pathogen detection group, with metagenomic sequencing samples derived from blood specimens. The study compares the pathogen detection rates and clinical diagnosis conformity rates of the aforementioned groups, as well as the efficiency of diagnosis in guiding clinical treatment.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed HIV infection;

2. Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDS opportunistic infections;

3. Age between 18 and 65 years;

4. Meeting the diagnosis of severe pneumonia or septic shock:

   1. The criteria for severe pneumonia diagnosis refer to the 2021 ATS (American Thoracic Society) and IDSA (Infectious Diseases Society of America) guidelines for the treatment of community-acquired pneumonia;
   2. The criteria for septic shock refer to the Chinese Society of Critical Care Medicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).

Exclusion criteria

1. Coexisting central nervous system lesions, severe liver disease, or cirrhosis;
2. Concurrent AIDS-related or unrelated tumors;
3. Women who are pregnant or breastfeeding;
4. Severe underlying diseases of the heart, lungs, liver, kidneys, etc.;
5. Alcohol abuse or drug use;
6. The researcher believes that the overall condition of the subject affects the evaluation and completion of the trial.

Trial design

400 participants in 2 patient groups

Pathogen metagenomic next-generation sequencing group

Description:

This group uses metagenomic next-generation sequencing along with traditional pathogen detection techniques to test for infectious pathogens. The follow-up times are the 1st, 2nd, 3rd, and 4th weeks after being diagnosed with severe pneumonia or sepsis.

Treatment:

Diagnostic Test: Pathogen metagenomic next-generation sequencing

Conventional pathogen detection group

Description:

This group only used conventional pathogen detection methods for the identification of infectious pathogens. Follow-up was conducted at the 1st, 2nd, 3rd, and 4th weeks after the diagnosis of severe pneumonia or sepsis. The conventional means of pathogen detection include, but are not limited to, fungal serology tests, cryptococcal capsular antigen detection, CMV-DNA tests, sputum smear microscopy, gamma interferon release assays, Xpert MTB/RIF, BLAF culture, blood and bone marrow cultures, radiological examinations, and histopathological examinations.