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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Pulmonary Infection

Intervention / Treatment
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* Diagnostic Test: mNGS, IDSeq UltraTM


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary Infection with DM group<br>Patients with diabetes and pulmonary infection | Diagnostic Test: mNGS, IDSeq UltraTM<br>* pathogen detection<br>|
| Pulmonary Infection group<br>Patients with pulmonary infection while the fasting blood-glucose in the normal range. | Diagnostic Test: mNGS, IDSeq UltraTM<br>* pathogen detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 28 Days | 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 | 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 | 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 |
| --- | --- | --- |
| 72h Treatment Response | response after infection treating 72 hours | disease treating 72 hours | 
| Hospitalization Time | 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 | 
| CURB-65 Score | 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 | 
| Inflammatory Parameters | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Infection, Diabetes Mellitus, mNGS, host immune response