Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

Last updated: November 17, 2023
Sponsor: Guangzhou 8th People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Pneumonia

Soft Tissue Infections

Treatment

Pathogen metagenomic next-generation sequencing

Clinical Study ID

NCT06145841
GZ8H-202322259s
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed HIV infection;
  2. Progression to AIDS stage: CD4+ count <200 cells/ul and/or occurrence of AIDSopportunistic infections;
  3. Age between 18 and 65 years;
  4. Meeting the diagnosis of severe pneumonia or septic shock:
  5. The criteria for severe pneumonia diagnosis refer to the 2021 ATS (AmericanThoracic Society) and IDSA (Infectious Diseases Society of America) guidelinesfor the treatment of community-acquired pneumonia;
  6. The criteria for septic shock refer to the Chinese Society of Critical CareMedicine's "Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018).

Exclusion

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 theevaluation and completion of the trial.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Pathogen metagenomic next-generation sequencing
Phase:
Study Start date:
October 23, 2023
Estimated Completion Date:
October 23, 2027

Study 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.

Connect with a study center

  • Linghua Li

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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