Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06145841

Enrollment

400

Registered

2023-11-24

Start date

2023-10-23

Completion date

2027-10-23

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, Pneumonia, Sepsis, Neonatal

Keywords

AIDS, severe pneumonia, Sepsis, metagenomic next-generation sequencing

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

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.

Interventions

DIAGNOSTIC_TESTPathogen 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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026