Clinical trial NCT03617393: Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections
Official title: A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Pulmonary Infection
Keywords: Early Warning Model
Clinical Pathway
Diabetes
Pulmonary Infection
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetes patients complicated with pulmonary infection

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 develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.

Detailed description: Investigators perform a observational study on 6000 patients with diabetes, among which 200 patients with pulmonary infection are included in a retrospective study and 100 patients go through metabolomics research. All patients receive clinical questionnaires, laboratory examinations and pulmonary function tests. Investigators study on pathogen distribution and infection ratio of patients above depending on follow-up survey. 1:1 nested case-control study is carried out involving 100 cases from pulmonary-infected group paired with 100 control cases matched for gender, age and fasting blood-glucose. The final purpose is to create a precise warning model in order to develop a rapid detection of pathogen of lower respiratory infection in diabetes patients. Now investigators wish to register this study to do a further research, in order to improve the early diagnosis 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
* Diagnosis through guideline of diabetes or history of diagnosed diabetes
* Age 40-70 years

Exclusion Criteria:

* Irregular follow-up and lost follow-up
* Withdraw from the study for any reason

Primary outcomes:
measure: Survival at 30 Days
timeFrame: 30 days from date of diagnosis of pulmonary infection until the date of death from any cause.
measure: Survival at 90 Days
timeFrame: 90 days from date of diagnosis of pulmonary infection until the date of death from any cause.
measure: Survival at 1 Year
timeFrame: 1 year from date of diagnosis of pulmonary infection until the date of death from any cause.
Secondary outcomes:
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: Sepsis
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, day 10-14 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: Fungal Infection Examinations
timeFrame: Day 0, day 3, day 10-14 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: Cryptococcal Infection Examinations
timeFrame: Day 0, day 3, day 10-14 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, day 10-14 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: Humoral Immunoserologic Indexes
timeFrame: Day 0, day 3, day 10-14 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: