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NCT03798925 Clinical Trial

mNGS for Detection of Pathogens for Pulmonary Infection

Pulmonary Infection Clinical Trial

Official title:
Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing for Pulmonary Infection in Clinical Settings

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03798925
Other study ID # SRRSH-mNGS-respiratory
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 19, 2018
Est. completion date February 2019

Study information
Verified date December 2018
Source Sir Run Run Shaw Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Pulmonary infection as the primary diagnosis

- Bronchoalveolar lavage fluid can be obtained

Exclusion Criteria:

- when the primary diagnosis is tumor or connective tissue diseases

- microbiological diagnosis is confirmed before bronchoalveolar lavage

- not enough bronchoalveolar lavage fluid for mNGS

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None Intervention
It is observational study

Locations
Country Name City State
China Sir Run Run Shaw Hospital Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary microbiological diagnosis (pathogen of pulmonary infection) the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations. through study completion, up to 6 months
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