Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections

Diabetes Mellitus Clinical Trial

Official title:

A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03617393
• Other study ID #: 2017YFC1309700
• Status: Active, not recruiting
• Start date: July 10, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2020
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6000
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetes Mellitus
• Infection
• Pulmonary Infection

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 30 Days	Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 30-day-survival of patients from different groups.	30 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Primary	Survival at 90 Days	Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 90-day-survival of patients from different groups.	90 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Primary	Survival at 1 Year	Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 1-year-survival of patients from different groups.	1 year from date of diagnosis of pulmonary infection until the date of death from any cause.
Secondary	Hospitalization Time	Differences in 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	Sepsis	Differences in the primary and secondary sepsis after therapy according to guideline 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, 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
Secondary	Fungal Infection Examinations	Assessment of G test and GM test in order to clarify the diagnosis of fungal infection.	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
Secondary	Cryptococcal Infection Examinations	Assessment latex agglutination test in order to clarify the cryptococcal infection.	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
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, 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
Secondary	Humoral Immunoserologic Indexes	Differences of IgG, IgA, IgE and IgM in different groups in order to research on cell-mediated immunity of patients with or without diabetes and pulmonary infection.	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