NCT03798925

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 10, 2019

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

December 29, 2018

Last Update Submit

January 7, 2019

Conditions

Pulmonary Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

None InterventionOTHER

It is observational study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained

You may qualify if:

  • Pulmonary infection as the primary diagnosis
  • Bronchoalveolar lavage fluid can be obtained

You may not qualify if:

  • when the primary diagnosis is tumor or connective tissue diseases
  • microbiological diagnosis is confirmed before bronchoalveolar lavage
  • not enough bronchoalveolar lavage fluid for mNGS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage fluid

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Infectious Diseases

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 10, 2019

Study Start

August 19, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 10, 2019

Record last verified: 2018-12

Locations

CN(1)