Diabetes MellitusNCT03617393
Study on Appropriate Technology of Standardized Diagnosis and Treatment for 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 develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Pulmonary Infection
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 1 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: diabetes patients complicated with pulmonary infection
Who may be able to join
- 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
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
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Pulmonary Infection
- Keywords
- Early Warning Model, Clinical Pathway, Diabetes, Pulmonary Infection
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Infection with DM group | Patients with diabetes and pulmonary infection. | |
| Pulmonary Infection group | Patients with pulmonary infection while the fasting blood-glucose in the normal range. | |
| DM group | Patients without pulmonary infection while the fasting blood-glucose > 8 mmol/L. | |
| Control group: normal people | Patients without pulmonary infection while the fasting blood-glucose in the normal range. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days from date of diagnosis of pulmonary infection until the date of death from any cause.
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.
Measured: 90 days from date of diagnosis of pulmonary infection until the date of death from any cause.
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.
Measured: 1 year from date of diagnosis of pulmonary infection until the date of death from any cause.
Secondary outcomes (8)
Hospitalization Time
Differences in 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
Sepsis
Differences in the primary and secondary sepsis after therapy according to guideline 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, 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
Fungal Infection Examinations
Assessment of G test and GM test in order to clarify the diagnosis of fungal infection.
Measured: 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
Cryptococcal Infection Examinations
Assessment latex agglutination test in order to clarify the cryptococcal infection.
Measured: 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
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, 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start10 Jul 2017
- Primary completion1 May 2019
- Study completion1 Dec 2021 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
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
- NCT03617393
- Sponsor's protocol ID
- 2017YFC1309700
- Status last verified
- Oct 2020
- First submitted
- 12 Jul 2018
- Last updated
- 8 Oct 2020
- 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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Complication of Pulmonary Infection
- ClinicalTrials.gov ID
- NCT03617393
- Acronym / sponsor ID
- 2017YFC1309700
- Conditions
- Diabetes Mellitus, Pulmonary Infection
- Keywords
- Early Warning Model, Clinical Pathway, Diabetes, Pulmonary Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 6 Aug 2018 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Infection with DM group | – | –Patients with diabetes and pulmonary infection. |
| Pulmonary Infection group | – | –Patients with pulmonary infection while the fasting blood-glucose in the normal range. |
| DM group | – | –Patients without pulmonary infection while the fasting blood-glucose > 8 mmol/L. |
| Control group: normal people | – | –Patients without pulmonary infection while the fasting blood-glucose in the normal range. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- diabetes patients complicated with pulmonary infection
Key inclusion criteria (4 listed)
- 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
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.
Primary outcome
Survival at 30 Days
Time frame: 30 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 30-day-survival of patients from different groups.
Survival at 90 Days
Time frame: 90 days from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 90-day-survival of patients from different groups.
Survival at 1 Year
Time frame: 1 year from date of diagnosis of pulmonary infection until the date of death from any cause.
Accuracy and sensitivity of novel survival prediction algorithm derived from differences between the predicted and actual 1-year-survival of patients from different groups.
8 secondary outcomes
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
Sepsis
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, 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
Fungal Infection Examinations
Time frame: 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
Cryptococcal Infection Examinations
Time frame: 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
Cell-mediated Immunoserologic Indexs
Time frame: 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
Humoral Immunoserologic Indexes
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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 4 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 8 Oct 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 30 Days (time frame: 30 days from date of diagnosis of pulmonary infection until the date of death from any cause.). 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 8 Oct 2020.