Trials / Unknown
UnknownNCT05552872
Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | mNGS, IDSeq UltraTM | pathogen detection |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2024-12-01
- Completion
- 2025-09-01
- First posted
- 2022-09-23
- Last updated
- 2022-09-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05552872. Inclusion in this directory is not an endorsement.