NCT05552872

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

September 21, 2022

Last Update Submit

September 22, 2022

Conditions

Diabetes MellitusPulmonary Infection

Keywords

Pulmonary InfectionDiabetes MellitusmNGShost immune response

Outcome Measures

Primary Outcomes (3)

  • Survival at 28 Days

    28 days from date of diagnosis of pulmonary infection until the date of death from any cause

    28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first

  • Survival at 14 Days

    14 days from date of diagnosis of pulmonary infection until the date of death from any cause

    14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first

  • Survival at 7 Days

    7 days from date of diagnosis of pulmonary infection until the date of death from any cause

    7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first

Secondary Outcomes (7)

  • 72h Treatment Response

    disease treating 72 hours

  • 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

  • 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

  • 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

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Pulmonary Infection with DM group

Patients with diabetes and pulmonary infection

Diagnostic Test: mNGS, IDSeq UltraTM

Pulmonary Infection group

Patients with pulmonary infection while the fasting blood-glucose in the normal range.

Diagnostic Test: mNGS, IDSeq UltraTM

Interventions

mNGS, IDSeq UltraTMDIAGNOSTIC_TEST

pathogen detection

Pulmonary Infection groupPulmonary Infection with DM group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Diagnosis by pathogen examination: positive * Diagnosis through X-ray or CT: characteristic features of pulmonary infection * Age older than 18 years

You may qualify if:

  • Diagnosis by pathogen examination: positive
  • Diagnosis through X-ray or CT: characteristic features of pulmonary infection
  • Age older than 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jieming Qu, Ph.D., M.D.

    China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Zhou, Ph.D., M.D.

CONTACT

+8613681779642doctor_zhou_99@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician of Department of Respiratory Medicine

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

September 1, 2022

Primary Completion

December 1, 2024

Study Completion

September 1, 2025

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)