NCT07895290 A Multicenter Randomized Trial of CT-Based AI Decision Support for Early Pneumonia Care
| NCT ID | NCT07895290 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Pneumonia; Pulmonary Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,800 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,800 participants in total. It began in 2026-01-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Adults hospitalized with pneumonia who need new or increased oxygen support or have defined immunocompromise will be assigned to usual care with or without access to a CT-based AI report. The report summarizes likely pathogen classes, lung involvement, and short-term deterioration risk. Clinicians review the report alongside images and clinical evidence and retain responsibility for testing and treatment. The trial asks whether AI-assisted care reduces death or new invasive respiratory or circulatory support within 28 days. Patients are followed after discharge through day 90.
Eligibility Criteria
Inclusion Criteria: 1. Hospitalized with suspected or confirmed pneumonia and new or progressive infection-compatible chest CT abnormalities. 2. At increased clinical risk: new or increased oxygen requirement above the stable pre-illness baseline attributable to the current pneumonia, OR protocol-defined immunocompromise. 3. A clinically indicated CT meeting the frozen input-quality criteria is available. Randomize within 24 hours after that CT and within 48 hours of documented recognition of the current pneumonia episode. 4. No primary qualifying organ support earlier in the current episode, at baseline, or already clinically indicated before allocation. 5. Written informed consent from the participant or an authorized representative before randomization. Exclusion Criteria: 1. No interpretable CT suitable for the locked model; a noninfectious diagnosis fully explains the findings without suspected concomitant pneumonia. 2. Qualifying invasive respiratory or circulatory support in the current episode, including support already clinically indicated even if not yet delivered. 3. Previous randomization in this trial; a concurrent interventional study that conflicts with the AI care strategy. 4. Known pregnancy, outside the initial intended-use population; breastfeeding alone is not an exclusion. 5. Exclusive comfort-focused care or a pre-existing ceiling of care that rules out both invasive ventilation and vasopressor support. 6. Consent cannot be obtained under the approved arrangements.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07895290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumonia; Pulmonary Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07895290 currently recruiting?
Yes, NCT07895290 is actively recruiting participants. Contact the research team at xiaoyuhan1123@163.com for enrollment information.
Where is the NCT07895290 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07895290 clinical trial?
NCT07895290 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 4,800 participants.