SepsisNCT07109310
A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections
An observational study of Sepsis and Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital.
Trial summary
This study adopted a prospective, single-center, open-label design, aiming to evaluate the efficacy of the RTI clinical outcome prediction model in predicting clinical outcomes in subjects with acute respiratory tract infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Acute Respiratory Distress Syndrome, Community Acquired Pneumonia
- What is being tested?
- RTImodel001
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute respiratory tract infections
Who may be able to join
- Community-acquired pneumonia group
- Age ≥18 years old;
- Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit; ④ Comply with the diagnostic criteria for community-acquired pneumonia in the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2016 Edition); ⑤ The time from onset to enrollment was ≤8 days. Sepsis Group
- Age ≥18 years old;
- Sign the informed consent form; ③ According to the researcher's judgment, be able to comply with the research visit;
- Patients who meets the sepsis 3.0 diagnostic criteria.
Who cannot join
- Respiratory failure related to underlying heart and lung diseases;
- Severe liver and kidney dysfunction, pregnancy or lactation period;
- Meet the indications for organ transplantation or have undergone organ transplantation surgery in the past; ④ Known HIV infection; ⑤ Screening: Those who have experienced unstable angina pectoris or myocardial infarction within 30 days prior to the screening and have not received vascular recanalization treatment, as well as those with extensive cerebral hemorrhage; ⑥ Situations where researchers determine that enrollment is not appropriate.
About this study
Official title: A Prospective, Single-Center Clinical Validation Study of Transcri Ptomics-Based Biomarkers for Predicting Respiratory Infection Progression and Prognosis
This study adopted a prospective, single-center, open-label design, aiming to evaluate the efficacy of the RTI clinical outcome prediction model in predicting clinical outcomes in subjects with acute respiratory tract infections.
In this study, the subjects were divided into the community-acquired pneumonia group and the sepsis group, including one baseline visit, one visit on the 7th day, and one visit on the 28th day.
During the research process, blood samples will be collected at the corresponding visiting points for the validation of the predictive model.
- Being tested
- RTImodel001
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTImodel001Diagnostic test
This model was developed through transcriptome sequencing combined with machine learning to predict the risk of disease progression and clinical outcomes of respiratory tract infections
| Study group | Role | What they receive |
|---|---|---|
| Community-acquired pneumonia/sepsis group | Not described Receives: Diagnostic Test: RTImodel001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.
Measured: From enrollment to the end of follow-up at 28 days
Secondary outcomes (2)
The changes of the seven-scale compared to the time of enrollment
Measured: From enrollment to the end of follow-up at 28 days
The changes in SOFA score compared to the time of enrollment.
Measured: From enrollment to the end of follow-up at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinlun Tian, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109310
- Sponsor's protocol ID
- RTIModel-001
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center Clinical Validation Study of Transcri Ptomics-Based Biomarkers for Predicting Respiratory Infection Progression and Prognosis
- ClinicalTrials.gov ID
- NCT07109310
- Acronym / sponsor ID
- RTIModel-001
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (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.
This study adopted a prospective, single-center, open-label design, aiming to evaluate the efficacy of the RTI clinical outcome prediction model in predicting clinical outcomes in subjects with acute respiratory tract infections.
In this study, the subjects were divided into the community-acquired pneumonia group and the sepsis group, including one baseline visit, one visit on the 7th day, and one visit on the 28th day.
During the research process, blood samples will be collected at the corresponding visiting points for the validation of the predictive model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-acquired pneumonia/sepsis group | – | Diagnostic Test: RTImodel001 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory tract infections
Key inclusion criteria (6 listed)
- Community-acquired pneumonia group
- Age ≥18 years old;
- Age ≥18 years old;
Key exclusion criteria (3 listed)
- Respiratory failure related to underlying heart and lung diseases;
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 |
|---|---|---|
| RTImodel001This model was developed through transcriptome sequencing combined with machine learning to predict the risk of disease progression and clinical outcomes of respiratory tract infections | Diagnostic test | Community-acquired pneumonia/sepsis group |
Primary outcome
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days.
Time frame: From enrollment to the end of follow-up at 28 days
2 secondary outcomes
The changes of the seven-scale compared to the time of enrollment
Time frame: From enrollment to the end of follow-up at 28 days
The changes in SOFA score compared to the time of enrollment.
Time frame: From enrollment to the end of follow-up at 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital.
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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Any of the following occurs: 1) Death; 2) Progress to sepsis (SOFA≥2 points); 3) Follow up for 28 days. (time frame: From enrollment to the end of follow-up at 28 days). 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 7 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.