mNGS for Detection of Pathogens for Pulmonary Infection

NCT ID: NCT03798925

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-19

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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None Intervention

It is observational study

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian-cang Zhou M.D.

Department of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ying-zhi Fang

Role: primary

+86 571 86006987

Other Identifiers

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SRRSH-mNGS-respiratory

Identifier Type: -

Identifier Source: org_study_id

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