Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

Sponsor

Guangzhou 8th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145841

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
AIDS Pneumonia Sepsis, Neonatal	Diagnostic Test: Pathogen metagenomic next-generation sequencing

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Clinical Application of Metagenomic Next-Generation Sequencing-Guided Anti-Infection Strategies in AIDS Patients With Severe Pneumonia and/or Sepsis

Actual Study Start Date :

Oct 23, 2023

Anticipated Primary Completion Date :

Oct 23, 2026

Anticipated Study Completion Date :

Oct 23, 2027

Arms and Interventions

Arm	Intervention/Treatment
Pathogen metagenomic next-generation sequencing group 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.	Diagnostic Test: Pathogen metagenomic next-generation sequencing In diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens
Conventional pathogen detection group 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.

Arm

Intervention/Treatment

Pathogen metagenomic next-generation sequencing group

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.

Diagnostic Test: Pathogen metagenomic next-generation sequencing

In diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens

Conventional pathogen detection group

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.

Outcome Measures

Primary Outcome Measures

Pathogen detection rate and clinical diagnosis concordance rate [4 weeks]
Analyze the concordance rate between the pathogen spectrum detected using pathogen metagenomics technology and the final clinical disease diagnosis.

Secondary Outcome Measures

Clinical treatment efficacy rate [4 weeks]
"Clinical treatment efficacy includes: 1) AIDS combined with severe pneumonia: pathogen clearance or quantitative change, PSI score, chest X-ray/chest CT; 2) AIDS combined with sepsis: pathogen clearance or quantitative change, SOFA score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed HIV infection;
Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDS opportunistic infections;
Age between 18 and 65 years;
Meeting the diagnosis of severe pneumonia or septic shock:
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;
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:

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