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A comparative study on the application of various mNGS techniques in the etiological diagnosis of lower respiratory tract infections

A comparative study on the application of various mNGS techniques in the etiological diagnosis of lower respiratory tract infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060252
Enrollment
Unknown
Registered
2022-05-23
Start date
2022-05-16
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lower respiratory tract infection

Interventions

Gold Standard:Conventional controlled laboratory tests refer to the 2018 Infectious Diseases Society of America and American Society for Microbiology guidelines for laboratory diagnosis of infectious
Index test:Consistency of results between mNGS and traditional methods, sensitivity, specificity, negative/positive coincidence rate of each detection method
DDDs, duration of antibiotic, hospital stay, mortality of subjects in each group.

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18 years and above; 2. Judged as suspected lower respiratory tract infection, among which lower respiratory tract pneumonia includes hospital-acquired pneumonia, community-acquired pneumonia, invasive pulmonary mycosis, and bronchiectasis complicated by infection. The specific diagnostic criteria are listed in Appendix I. The diagnostic criteria of the disease refer to the corresponding guidelines. For hospital-acquired pneumonia, refer to the 2016 American Thoracic Society and Infectious Diseases Society Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia, and for community-acquired pneumonia, refer to the 2019 guidelines. American Thoracic Society and Society of Infectious Diseases guidelines for the diagnosis and management of community-acquired pneumonia; invasive pulmonary mycosis with reference to the 2019 European Organization for Cancer Research and Treatment and Mycosis Study Group Education and Research Consortium (EORTC/MSG) Revision and update of the consensus definition of venereal mycosis; bronchiectasis and infection refer to the 2019 British Thoracic Society adult bronchiectasis guidelines; 3. Complete and complete clinical information; 4. Be able to communicate in language or writing, agree to participate in this study and sign informed consent, and be able to complete the test-related inspections.

Exclusion criteria

Exclusion criteria: 1. There are contraindications for tracheoscopy, such as blood coagulation dysfunction and platelet count below 50 * 10 ^ 9/L; 2. Known to be infected with human immunodeficiency virus or novel coronavirus; 3. Patients who cannot understand and implement the investigation plan; 4. Pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
Sensitivity of different mNGS techniques for pathogenic diagnosis of lower respiratory tract infection;The specificity of different mNGS techniques for the etiological diagnosis of lower respiratory tract infection;

Secondary

MeasureTime frame
defined daily dose of antibiotic;Course of antibiotics;Length of stay;Mortality rate;Positive Predictive Value;Negative Predictive Value;

Countries

China

Contacts

Public ContactYe Feng

The First Affiliated Hospital of Guangzhou Medical University

yefeng@gird.cn+86 20 83205181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026