Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections

September 22, 2022 updated by: ZHOU Min, Ruijin Hospital

A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections

Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to explore the lower respiratory microenvironment and host immune response and then make an application in clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators perform a cross-sectional multicenter study on patients with pulmonary infection. All patients receive clinical questionnaires, laboratory examinations and treatment monitoring. Routine clinical pathogen culture and mNGS are both carried out on pathogen detection. Among participants in IDSeq UltraTM group, 1:2 nested case-control study is carried out involving 77 cases from pulmonary-infected group paired with 154 control cases and peripheral blood RNA-seq is carried out between pneumonia patients with diabetes and pneumonia patients without diabetes matched for gender, age and fasting blood-glucose.

The final purpose is to find out the difference in etiologic spectrum and host immune on lower respiratory infection between diabetes patients and controls. Now investigators wish to register this study to do a further research, in order to improve the diagnosis value of diabetes complicated with pulmonary infection and to reduce the mortality.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Diagnosis by pathogen examination: positive
  • Diagnosis through X-ray or CT: characteristic features of pulmonary infection
  • Age older than 18 years

Description

Inclusion Criteria:

  • Diagnosis by pathogen examination: positive
  • Diagnosis through X-ray or CT: characteristic features of pulmonary infection
  • Age older than 18 years

Exclusion Criteria:

  • Irregular follow-up and lost follow-up
  • Withdraw from the study for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pulmonary Infection group
Patients with pulmonary infection while the fasting blood-glucose in the normal range.
Diagnostic test: mNGS, IDSeq UltraTM
pathogen detection
Pulmonary Infection with DM group
Patients with diabetes and pulmonary infection
Diagnostic test: mNGS, IDSeq UltraTM
pathogen detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival at 28 Days
Time Frame: 28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
28 days from date of diagnosis of pulmonary infection until the date of death from any cause
28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
Survival at 14 Days
Time Frame: 14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
14 days from date of diagnosis of pulmonary infection until the date of death from any cause
14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
Survival at 7 Days
Time Frame: 7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
7 days from date of diagnosis of pulmonary infection until the date of death from any cause
7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CURB-65 Score
Time Frame: Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
Differences in confusion, urea, respiratory rate and age 65 scoring system from different groups.
Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
72h Treatment Response
Time Frame: disease treating 72 hours
response after infection treating 72 hours
disease treating 72 hours
Hospitalization Time
Time Frame: Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
the time of hospital stay including ordinary sickroom and ICU of patients from different groups
Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
Inflammatory Parameters
Time Frame: Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
Differences in CRP, PCT, IL-6, IL-8, TNF-α from different groups.
Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
Cell-mediated Immunoserologic Indexs
Time Frame: Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
Differences of CD3, CD4 and CD8 in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection
Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
PSI Indexs
Time Frame: Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
Pneumonia severity index grade, including age, comorbidities, signs, blood gases
Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
SOFA Indexs
Time Frame: Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years
Sequential Organ Failure Assessment
Day 0, day 3, day7-14 and final result from date of diagnosis of pulmonary infection until the date of death or cure from any cause, assessed up to 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (ACTUAL)

September 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022Ultra

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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