The Value of mNGS in Diagnosis of Pulmonary Infection

Pulmonary Infection Clinical Trial

Official title:

To Explore the Application of mNGS Detection Technology in the Diagnosis of Pulmonary Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307405
• Other study ID #: WJP2023
• Status: Not yet recruiting
• Start date: April 20, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: Qianfoshan Hospital
• Contact: Yunfeng Hou, master
• Phone: 18660150596
• Email: 258370615[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Pulmonary infection is a common type of respiratory infection that can lead to multiple complications and is considered the most important infectious disease worldwide due to its high morbidity and mortality. Lung infections, caused by one or more pathogens such as bacteria, viruses, fungi and parasites, are not easily distinguishable clinically and are among the top 10 causes of death worldwide. Therefore, early and accurate identification of the cause of infection for patients with pulmonary infection is of great significance for subsequent treatment and improvement of prognosis. At present, the main traditional diagnostic methods for pulmonary infection are microbial culture, antigen and antibody detection and PCR nucleic acid detection technology. Although microbial culture is the gold standard for microbial identification, it takes a long time to detect some viruses and parasites. The sensitivity of antigen and antibody detection is poor. PCR nucleic acid detection method has high sensitivity and specificity, but it can not detect all pathogens causing lung infection. Therefore, it is necessary to develop a fast, convenient and sensitive new detection technology to detect the pathogen of pulmonary infection. next generation sequencing (NGS) has the advantage of no assumptions and no dependence on culture, and can detect all pathogens in clinical samples without bias, and has been widely used in a variety of infectious diseases. This study collected the basic information of patients suspected of pulmonary infection in clinic, and conducted mNGS detection and routine pathogen detection on different samples of alveolar lavage fluid (BALF) and sputum, respectively, to evaluate the consistency of mNGS detection and routine detection and the positive pathogen detection rate, as well as the clinical application value of mNGS detection.

This study retrospectively analyzed 50 patients hospitalized in our hospital from January, 2019 to October, 2019, 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.

Clinical data of relevant patients were collected, including gender, age, smoking status, clinical manifestations, length of stay before mNGS detection, antibiotic use before mNGS detection, imaging changes, laboratory examination and other basic information. Results were collected from study participants' alveolar lavage fluid (BALF), sputum for traditional pathogen tests (microbial culture and PCR nucleic acid detection techniques), and mNGS tests. The positive rate of pathogen detection and the consistency of detection results of the two detection methods were compared.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 30, 2025
• Est. primary completion date: April 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Inclusion criteria: Patients meeting diagnostic criteria for pulmonary infection between January 1, 2020 and October 31, 2023. Patients with pulmonary infection were diagnosed with new or worsening focal or diffuse infiltrating lesions on chest CT accompanied by at least one of the following four pneumonic-related clinical manifestations: (1) Recent cough, sputum, or aggravation of existing respiratory symptoms with or without purulent sputum, chest pain, dyspnea, and hemoptysis; ? Heat, T=38?; ? Signs of lung consolidation and/or smell and moist rales; ? Peripheral blood white blood cell count > 10*109/L or < 4*109/L.

Exclusion criteria: ? The patient did not undergo bronchoscopy; Absence of clinical or laboratory data.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pulmonary Infection

Intervention

Diagnostic Test:
• next generation sequencing
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yunfeng Hou

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Consistency of detection results 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, were compared for the consistency of pathogen detection results between the two assays	From January 1, 2020 to October 31, 2023