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Clinical study of Mifepristone in the treatment of TBI combined with pulmonary infection

Clinical study of Mifepristone in the treatment of TBI combined with pulmonary infection

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099027
Enrollment
Unknown
Registered
2025-03-18
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Interventions

Conventional treatment group:The usual treatment group received routine anti-infective therapy, respiratory support, improved lung drainage, expectoration, supportive therapy, prevention and monitorin

Sponsors

Affiliated Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with TBI through medical history collection and imaging (such as CT) with a GCS score 30 ml; 2. Patients over 65 years old, regardless of gender; 3. Time from onset to surgery <=72 hours, and no complications such as intracranial rebleeding or intracranial infection after surgery; 4. Meeting the diagnostic criteria for hospital-acquired pneumonia (HAP): specific indicators may include: clinical manifestations: fever, cough, purulent sputum, etc.; respiratory-related symptoms: tachypnea or hypoxemia; laboratory and imaging evidence: pulmonary infiltration or lesions shown on chest imaging; elevated or decreased white blood cell count in blood routine, elevated C-reactive protein (CRP) or procalcitonin (PCT); positive results from sputum culture or other microbiological tests; 5. Stable postoperative condition with stable basic vital signs; 6. BALF flow cytometry: proportion of HLA-DR+ neutrophils < 2%; 7. Basic liver and kidney functions are normal or only slightly abnormal, which do not affect drug metabolism and excretion at the study dose, with ALT and AST <= 2 times the upper limit of normal and serum creatinine <= 1.5 times the upper limit of normal.

Exclusion criteria

Exclusion criteria: 1. Non-supratentorial intracerebral hemorrhage; 2. Secondary intracerebral hemorrhage (secondary causes such as aneurysms, vascular malformations, hemorrhagic transformation of cerebral infarction, tumors, drug-related or abnormal coagulation mechanisms, etc.); patients with brain herniation; 3. Severe TBI or with severe basilar skull fractures; 4. TBI patients with concurrent injuries to other organs; 5. Patients judged by the researcher to have poor compliance, mental problems preventing informed consent, or whose families refuse to participate in the study; 6. Patients allergic to this drug; 7. Patients with abnormal heart, liver, or kidney function, or with a history of heart, liver, or kidney diseases; 8. Patients who may be pregnant in the near future, are already pregnant, are in the lactation period, or refuse to use contraception within six months of administration; patients with intrauterine device pregnancy and suspected ectopic pregnancy; 9. Patients with a history of uncontrollable infection or severe infectious diseases; 10. Patients who have received a vaccine within 30 days of administration; 11. Patients currently with diabetes, cardiovascular diseases, a history of pulmonary diseases, immunodeficiency diseases, or other serious diseases that may interfere with outcome assessment.

Design outcomes

Primary

MeasureTime frame
The difference of negative conversion rate of bacterial culture in BALF after mifepristone treatment;

Secondary

MeasureTime frame
Proportion of HLA-DR+ neutrophils in BALF;Expression of inflammatory factors in BALF;Body temperature;Respiratory function index: FEV1, FVC;Chest computed tomography;

Countries

China

Contacts

Public ContactWei Shi

Affiliated Hospital of Nantong University

fysw@ntu.edu.cn+86 135 8522 5222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026