Diabetes Mellitus, Pulmonary Infection
Conditions
Keywords
Pulmonary Infection, Diabetes Mellitus, mNGS, host immune response
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.
Interventions
DIAGNOSTIC_TESTmNGS, IDSeq UltraTM
pathogen detection
Sponsors
Ruijin Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 72h Treatment Response | disease treating 72 hours | response after infection treating 72 hours |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactMin Zhou, Ph.D., M.D.
Outcome results
None listed