The Value of mNGS in Diagnosis of Pulmonary Infection

NCT06307405 | Not Yet Recruiting

• 1 other identifier: WJP2023
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis.

Conditions

Pulmonary Infection

Keywords

Metagenomic next-generation sequencing，Pulmonary Infection

Outcome Measures

Primary Outcomes (1)

• Etiological detection rates of two detection techniques

  Study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively, compared the positive rates of pathogen detection by the two detection methods

  From January 1, 2020 to October 31, 2023

Secondary Outcomes (1)

• Consistency of detection results of two detection techniques

  From January 1, 2020 to October 31, 2023

Study Arms (1)

pulmonry infection group

50 cases of suspected pulmonary infection (based on clinical manifestations and imaging findings). These patients have collected two different samples of alveolar lavage fluid (BALF) and sputum and have undergone metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively.

Diagnostic Test: next generation sequencing

Interventions

next generation sequencing DIAGNOSTIC_TEST

All the enrolled patients had undergone fiberbronchoscopy and sputum had been retained. The collected alveolar lavage fluid and sputum were examined for mNGS and routine etiology, respectively

Also known as: mNGS

pulmonry infection group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients whose symptoms, signs, imaging, and infection indicators met the diagnostic criteria for pulmonary infection while routine etiological detection of sputum and pulmonary alveolar lavage fluid mNGS were performed.

Sponsors & Collaborators

• Yunfeng Hou: lead

Related Publications (6)

• Qian YY, Wang HY, Zhou Y, Zhang HC, Zhu YM, Zhou X, Ying Y, Cui P, Wu HL, Zhang WH, Jin JL, Ai JW. Improving Pulmonary Infection Diagnosis with Metagenomic Next Generation Sequencing. Front Cell Infect Microbiol. 2021 Jan 26;10:567615. doi: 10.3389/fcimb.2020.567615. eCollection 2020.

  PMID: 33585263 BACKGROUND

• Langelier C, Kalantar KL, Moazed F, Wilson MR, Crawford ED, Deiss T, Belzer A, Bolourchi S, Caldera S, Fung M, Jauregui A, Malcolm K, Lyden A, Khan L, Vessel K, Quan J, Zinter M, Chiu CY, Chow ED, Wilson J, Miller S, Matthay MA, Pollard KS, Christenson S, Calfee CS, DeRisi JL. Integrating host response and unbiased microbe detection for lower respiratory tract infection diagnosis in critically ill adults. Proc Natl Acad Sci U S A. 2018 Dec 26;115(52):E12353-E12362. doi: 10.1073/pnas.1809700115. Epub 2018 Nov 27.

  PMID: 30482864 BACKGROUND

• Shi CL, Han P, Tang PJ, Chen MM, Ye ZJ, Wu MY, Shen J, Wu HY, Tan ZQ, Yu X, Rao GH, Zhang JP. Clinical metagenomic sequencing for diagnosis of pulmonary tuberculosis. J Infect. 2020 Oct;81(4):567-574. doi: 10.1016/j.jinf.2020.08.004. Epub 2020 Aug 5.

  PMID: 32768450 BACKGROUND

• Yan L, Sun W, Lu Z, Fan L. Metagenomic Next-Generation Sequencing (mNGS) in cerebrospinal fluid for rapid diagnosis of Tuberculosis meningitis in HIV-negative population. Int J Infect Dis. 2020 Jul;96:270-275. doi: 10.1016/j.ijid.2020.04.048. Epub 2020 Apr 24.

  PMID: 32339718 BACKGROUND

• Wilson MR, Sample HA, Zorn KC, Arevalo S, Yu G, Neuhaus J, Federman S, Stryke D, Briggs B, Langelier C, Berger A, Douglas V, Josephson SA, Chow FC, Fulton BD, DeRisi JL, Gelfand JM, Naccache SN, Bender J, Dien Bard J, Murkey J, Carlson M, Vespa PM, Vijayan T, Allyn PR, Campeau S, Humphries RM, Klausner JD, Ganzon CD, Memar F, Ocampo NA, Zimmermann LL, Cohen SH, Polage CR, DeBiasi RL, Haller B, Dallas R, Maron G, Hayden R, Messacar K, Dominguez SR, Miller S, Chiu CY. Clinical Metagenomic Sequencing for Diagnosis of Meningitis and Encephalitis. N Engl J Med. 2019 Jun 13;380(24):2327-2340. doi: 10.1056/NEJMoa1803396.

  PMID: 31189036 BACKGROUND

• Fida M, Wolf MJ, Hamdi A, Vijayvargiya P, Esquer Garrigos Z, Khalil S, Greenwood-Quaintance KE, Thoendel MJ, Patel R. Detection of Pathogenic Bacteria From Septic Patients Using 16S Ribosomal RNA Gene-Targeted Metagenomic Sequencing. Clin Infect Dis. 2021 Oct 5;73(7):1165-1172. doi: 10.1093/cid/ciab349.

  PMID: 33893492 BACKGROUND

Study Officials

• Yunfeng Hou, master

  Department of Intensive Care Medicine, Qiandfo Mountain Hospital, Shandong Province

  STUDY DIRECTOR

Central Study Contacts

Yunfeng Hou, master

CONTACT

18660150596; 258370615@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: April 20, 2024
• Primary Completion: April 20, 2025
• Study Completion: September 30, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share