Clinical trial NCT05552872: Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
Official title: A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Pulmonary Infection
Keywords: Pulmonary Infection
Diabetes Mellitus
mNGS
host immune response
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Diagnosis by pathogen examination: positive
* Diagnosis through X-ray or CT: characteristic features of pulmonary infection
* Age older than 18 years

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival at 28 Days
timeFrame: 28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
measure: Survival at 14 Days
timeFrame: 14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
measure: Survival at 7 Days
timeFrame: 7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
Secondary outcomes:
measure: 72h Treatment Response
timeFrame: disease treating 72 hours
measure: Hospitalization Time
timeFrame: Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
measure: CURB-65 Score
timeFrame: Every 6 months from date of diagnosis of pulmonary infection until the date of death from any cause, assessed up to 3 years
measure: Inflammatory Parameters
timeFrame: 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
measure: Cell-mediated Immunoserologic Indexs
timeFrame: 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
measure: PSI Indexs
timeFrame: 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
measure: SOFA Indexs
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine
name: Jieming Qu, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: