Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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AIDS, Pneumonia, Sepsis, Neonatal

Intervention / Treatment
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* Diagnostic Test: Pathogen metagenomic next-generation sequencing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pathogen metagenomic next-generation sequencing group<br>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<br>* In diagnosing patients with AIDS combined with severe pneumonia and/or sepsis, use pathogen metagenomics technology to detect peripheral blood specimens<br>|
| Conventional pathogen detection group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathogen detection rate and clinical diagnosis concordance rate | Analyze the concordance rate between the pathogen spectrum detected using pathogen metagenomics technology and the final clinical disease diagnosis. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical treatment efficacy rate | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS, severe pneumonia, Sepsis, metagenomic next-generation sequencing