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

Overview

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

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 1, 2024

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.

Interventions

• Diagnostic Test: mNGS, IDSeq UltraTM
  • pathogen detection

Arms, Groups and Cohorts

• Pulmonary Infection with DM group
  • Patients with diabetes and pulmonary infection
• Pulmonary Infection group
  • Patients with pulmonary infection while the fasting blood-glucose in the normal range.

Clinical Trial Outcome Measures

Primary Measures

• 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
• 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
• 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

Secondary Measures

• 72h Treatment Response
  • Time Frame: disease treating 72 hours
  • response after infection 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
• 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.
• 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.
• 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
• 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
• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Ruijin Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: ZHOU Min, Chief Physician of Department of Respiratory Medicine – Ruijin Hospital
• Overall Official(s)
  • Jieming Qu, Ph.D., M.D., Principal Investigator, China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine
• Overall Contact(s)
  • Min Zhou, Ph.D., M.D., +8613681779642, doctor_zhou_99@163.com