Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
- Conditions
- Pulmonary InfectionDiabetes Mellitus
- Interventions
- Diagnostic Test: mNGS, IDSeq UltraTM
- Registration Number
- NCT05552872
- Lead Sponsor
- Ruijin Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Diagnosis by pathogen examination: positive
- Diagnosis through X-ray or CT: characteristic features of pulmonary infection
- Age older than 18 years
- Irregular follow-up and lost follow-up
- Withdraw from the study for any reason
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pulmonary Infection group mNGS, IDSeq UltraTM Patients with pulmonary infection while the fasting blood-glucose in the normal range. Pulmonary Infection with DM group mNGS, IDSeq UltraTM Patients with diabetes and pulmonary infection
- Primary Outcome Measures
Name Time Method Survival at 28 Days 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 7 Days 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
Survival at 14 Days 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
- Secondary Outcome Measures
Name Time Method Hospitalization Time 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
PSI Indexs 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
72h Treatment Response disease treating 72 hours response after infection treating 72 hours
CURB-65 Score 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.
Cell-mediated Immunoserologic Indexs 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
SOFA Indexs 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
Inflammatory Parameters 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.
Trial Locations
- Locations (1)
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China