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

NCT ID: NCT05552872

Last Updated: 2022-09-23

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus Pulmonary Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Infection with DM group

Patients with diabetes and pulmonary infection

mNGS, IDSeq UltraTM

Intervention Type DIAGNOSTIC_TEST

pathogen detection

Pulmonary Infection group

Patients with pulmonary infection while the fasting blood-glucose in the normal range.

mNGS, IDSeq UltraTM

Intervention Type DIAGNOSTIC_TEST

pathogen detection

Interventions

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mNGS, IDSeq UltraTM

pathogen detection

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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ZHOU Min

Chief Physician of Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jieming Qu, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Locations

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Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Zhou, Ph.D., M.D.

Role: CONTACT

+8613681779642

Facility Contacts

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Jieming QU, Ph.D., M.D.

Role: primary

+86 18317030297

Other Identifiers

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2022Ultra

Identifier Type: -

Identifier Source: org_study_id

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