Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Pathogen detection rate and clinical diagnosis concordance rate [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Clinical treatment efficacy rate [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Linghua Li — Гуанчжоу

Публикации

• Barbier F, Mer M, Szychowiak P, Miller RF, Mariotte E, Galicier L, Bouadma L, Tattevin P, Azoulay E. Management of HIV-infected patients in the intensive care unit. Intensive Care Med. 2020 Feb;46(2):329-342. doi: 10.1007/s00134-020-05945-3. Epub 2020 Feb 3. PMID 32016535
• Besser J, Carleton HA, Gerner-Smidt P, Lindsey RL, Trees E. Next-generation sequencing technologies and their application to the study and control of bacterial infections. Clin Microbiol Infect. 2018 Apr;24(4):335-341. doi: 10.1016/j.cmi.2017.10.013. Epub 2017 Oct 23. PMID 29074157
• Pei F, Yao RQ, Ren C, Bahrami S, Billiar TR, Chaudry IH, Chen DC, Chen XL, Cui N, Fang XM, Kang Y, Li WQ, Li WX, Liang HP, Lin HY, Liu KX, Lu B, Lu ZQ, Maegele M, Peng TQ, Shang Y, Su L, Sun BW, Wang CS, Wang J, Wang JH, Wang P, Xie JF, Xie LX, Zhang LN, Zingarelli B, Guan XD, Wu JF, Yao YM; Shock and Sepsis Society of Chinese Research Hospital Association; China Critical Care Immunotherapy Resear PMID 36567402

Идентификаторы

NCT: NCT06145841 · GZ8H-202322259s

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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