Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies

NCT06145841 | Recruiting

• 1 other identifier: GZ8H-202322259s
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

AIDS; Pneumonia; Sepsis, Neonatal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical treatment efficacy rate

  4 weeks

Study Arms (2)

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

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.

Interventions

Pathogen metagenomic next-generation sequencing DIAGNOSTIC_TEST

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

Pathogen metagenomic next-generation sequencing group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All study participants come from the OSPWH (Patients With HIV/AIDS) cohort at the Guangzhou Eighth People's Hospital.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou 8th People's Hospital: lead

Study Sites (1)

Linghua Li

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 Research Group; International Federation of the Shock Societies (IFSS). Expert consensus on the monitoring and treatment of sepsis-induced immunosuppression. Mil Med Res. 2022 Dec 26;9(1):74. doi: 10.1186/s40779-022-00430-y.

  PMID: 36567402 RESULT

Biospecimen

Retention: NONE RETAINED

Reserved biological samples are derived from peripheral blood specimens, used for pathogen metagenomic next-generation sequencing.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Pneumonia; Neonatal Sepsis; Sepsis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2027
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)