Diabetes MellitusNCT05552872
Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
An observational study of Diabetes Mellitus and Pulmonary Infection, run by Ruijin Hospital at 1 site in China.
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 explore the lower respiratory microenvironment and host immune response and then make an application in clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Pulmonary Infection
- What is being tested?
- mNGS, IDSeq UltraTM
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Sep 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Diagnosis by pathogen examination: positive * Diagnosis through X-ray or CT: characteristic features of pulmonary infection * Age older than 18 years
Who may be able to join
- Diagnosis by pathogen examination: positive
- Diagnosis through X-ray or CT: characteristic features of pulmonary infection
- Age older than 18 years
Who cannot join
- Irregular follow-up and lost follow-up
- Withdraw from the study for any reason
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jieming QU, Ph.D., M.D., +86 18317030297, jmqu0906@163.com
About this study
Official title: A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
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.
Read the 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
- Diabetes Mellitus, Pulmonary Infection
- Being tested
- mNGS, IDSeq UltraTM
- Keywords
- Pulmonary Infection, Diabetes Mellitus, mNGS, host immune response
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGS, IDSeq UltraTMDiagnostic test
pathogen detection
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Infection with DM group | Patients with diabetes and pulmonary infection Receives: Diagnostic Test: mNGS, IDSeq UltraTM | |
| Pulmonary Infection group | Patients with pulmonary infection while the fasting blood-glucose in the normal range. Receives: Diagnostic Test: mNGS, IDSeq UltraTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 28 Days
28 days from date of diagnosis of pulmonary infection until the date of death from any cause
Measured: 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
Measured: 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
Measured: 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
response after infection treating 72 hours
Measured: disease treating 72 hours
Hospitalization Time
the time of hospital stay including ordinary sickroom and ICU of patients from different groups
Measured: 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
Differences in confusion, urea, respiratory rate and age 65 scoring system from different groups.
Measured: 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
Differences in CRP, PCT, IL-6, IL-8, TNF-α from different groups.
Measured: 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
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
Measured: 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
PSI Indexs
Pneumonia severity index grade, including age, comorbidities, signs, blood gases
Measured: 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
SOFA Indexs
Sequential Organ Failure Assessment
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU Min, Ruijin Hospital
- Investigators
- Jieming Qu, Ph.D., M.D., Principal investigator, China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552872
- Sponsor's protocol ID
- 2022Ultra
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on Diagnosis Value of mNGS Technology Among Diabetic Patients With Pulmonary Infections
- ClinicalTrials.gov ID
- NCT05552872
- Acronym / sponsor ID
- 2022Ultra
- Conditions
- Diabetes Mellitus, Pulmonary Infection
- Keywords
- Pulmonary Infection, Diabetes Mellitus, mNGS, host immune response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Infection with DM group | – | Diagnostic Test: mNGS, IDSeq UltraTMPatients with diabetes and pulmonary infection |
| Pulmonary Infection group | – | Diagnostic Test: mNGS, IDSeq UltraTMPatients with pulmonary infection while the fasting blood-glucose in the normal range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Diagnosis by pathogen examination: positive * Diagnosis through X-ray or CT: characteristic features of pulmonary infection * Age older than 18 years
Key inclusion criteria (3 listed)
- Diagnosis by pathogen examination: positive
- Diagnosis through X-ray or CT: characteristic features of pulmonary infection
- Age older than 18 years
Key exclusion criteria (2 listed)
- Irregular follow-up and lost follow-up
- Withdraw from the study for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGS, IDSeq UltraTMpathogen detection | Diagnostic test | Pulmonary Infection group, Pulmonary Infection with DM group |
Primary outcome
Survival at 28 Days
Time frame: 28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
28 days from date of diagnosis of pulmonary infection until the date of death from any cause
Survival at 14 Days
Time frame: 14 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
14 days from date of diagnosis of pulmonary infection until the date of death from any cause
Survival at 7 Days
Time frame: 7 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first
7 days from date of diagnosis of pulmonary infection until the date of death from any cause
7 secondary outcomes
72h Treatment Response
Time frame: disease treating 72 hours
Hospitalization Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
PSI Indexs
Time frame: 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
SOFA Indexs
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieming Qu, Ph.D., M.D. principal investigator
China, Shanghai Ruijin Hospital Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Pulmonary Infection, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Zhou, Ph.D., M.D. (+8613681779642, doctor_zhou_99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 28 Days (time frame: 28 days from date of diagnosis of pulmonary infection until the date of death from any cause, whichever came first). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.