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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Diabetes Mellitus
Pulmonary Infection

Treatments

Diagnostic Test: mNGS, IDSeq UltraTM

Study type

Observational

Funder types

Other

Identifiers

NCT05552872
2022Ultra

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Pulmonary Infection with DM group
Description:
Patients with diabetes and pulmonary infection
Treatment:
Diagnostic Test: mNGS, IDSeq UltraTM
Pulmonary Infection group
Description:
Patients with pulmonary infection while the fasting blood-glucose in the normal range.
Treatment:
Diagnostic Test: mNGS, IDSeq UltraTM

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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