An interventional study of CT-Based AI Decision Support for Pneumonia in Pneumonia; Pulmonary Infection, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment
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.
This pragmatic, multicenter superiority trial uses individual 1:1 randomization and blinded outcome adjudication. Patients must be enrolled early in the pneumonia episode and before any qualifying primary organ-support event. Both groups receive the same scheduled clinical reviews and access to routine investigations. Only the AI group receives patient-specific AI results. The trial estimates the effect of offering the defined AI-assisted care strategy, including cases of report failure or clinician disagreement.
The intervention is evaluated through a prespecified sequence of evidence: report delivery and review; changes in pathogen testing, antimicrobial treatment, and monitoring; and patient outcomes. Technical diagnostic performance is secondary. All randomized patients enter the primary intention-to-treat analysis, including those subsequently found to have a noninfectious diagnosis. Recruitment spans multiple seasons and includes general respiratory, infectious-disease, and hematology services without requiring a hematologic disorder.
2,074 studies on the registry are indexed under Pneumonia; 286 are open to participants now.
This study's planned enrollment of 4,800 is above the median of 107 across 1,263 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 174 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
Usual care plus access to the locked AI report and documented review of its relevance to diagnosis and management.
Device: CT-Based AI Decision Support for Pneumonia
The same clinical review schedule and documentation, without access to trial AI outputs.
A locked CT-based artificial intelligence (AI) clinical decision-support system will analyze chest CT scans obtained as part of routine clinical care for patients with pneumonia. The system provides probabilities for predefined pathogen classes, quantitative assessment of pulmonary lesion extent, longitudinal changes when prior CT scans are available, and estimates of short-term clinical deterioration risk. For patients assigned to the intervention group, the AI-generated report will be made available to treating clinicians, with a target availability within one hour after randomization. Clinicians will review the AI findings alongside the original CT images and other clinical information within two hours and document any resulting changes in diagnosis, further testing, treatment, or monitoring. The AI system supports clinical decision-making but does not replace physician judgment. Additional CT scans are not required, and subsequent clinically indicated scans may also be analyzed.
Death or New Invasive Respiratory or Circulatory Support Within 28 Days
Time frame: From randomization to 28 completed days, including events after discharge, readmission, or transfer.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Share a de-identified analysis dataset and data dictionary supporting the primary publication through controlled access. Raw imaging and directly identifying records are excluded from routine release.
Started Jan 2026 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
Of 293 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 24 months is above that.
Counting every sponsor, half of 303 studies reached it within 21 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →