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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552872
• Other study ID #: 2022Ultra
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2022
• Source: Ruijin Hospital
• Contact: Min Zhou, Ph.D., M.D.
• Phone: +8613681779642
• Email: doctor_zhou_99[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetes Mellitus
• Infections
• Pulmonary Infection

Intervention

Diagnostic Test:
• mNGS, IDSeq UltraTM
pathogen detection

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	72h Treatment Response	response after infection treating 72 hours	disease treating 72 hours
Secondary	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
Secondary	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
Secondary	Inflammatory Parameters	Differences in CRP, PCT, IL-6, IL-8, TNF-a 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
Secondary	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
Secondary	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
Secondary	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