NCT06549374 Kinetics of INF-γ Production in Intensive Care Patients
| NCT ID | NCT06549374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Intensive Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-04-24 |
| Primary Completion | 2026-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-04-24 with a primary completion date of 2026-10-24.
⚠ 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
Most patients admitted to intensive care after severe trauma, high-risk surgery, or acute respiratory distress are frequently characterized by significant initial inflammation accompanied by a compensatory anti-inflammatory response, which can lead to profound post-aggressive immunosuppression. This immunosuppression is associated with an increased risk of nosocomial infections, viral reactivations, prolonged ICU stays, and ultimately, increased mortality. Consequently, immunostimulation with agents such as interferon gamma (IFN-γ) has been proposed as a means to restore immune defense in the most severe patients. However, in a recent study conducted on mechanically ventilated patients with acute organ failure, treatment with interferon gamma-1b compared to placebo did not significantly reduce the incidence of nosocomial pneumonia or 28-day mortality and was even associated with an increase in severe side effects, leading to the premature termination of the trial. These results, along with previous studies, suggest that for IFN-γ to be effective, it must be targeted at patients who have reached the immunosuppressive phase. In the absence of evident clinical signs, the use of biomarkers could guide clinicians in identifying the appropriate patients and the optimal timing for this therapy. In a recent monocentric study, they evaluated a new automated IFN-γ assay on a cohort of 22 septic patients to monitor T lymphocyte functionality independently of antigen. As expected, the results showed a marked decrease in IFN-γ release, which correlated with altered classical cellular parameters (CD8+ T cells, mHLA-DR). Since the test is performed using whole blood, requires no technician intervention, and provides results within four hours, this project propose to characterize the evolution of the immune status of a large cohort of ICU patients, including those with severe trauma, high-risk surgery, or acute respiratory distress syndrome.
Eligibility Criteria
Inclusion Criteria: * Aged 18 years or older * Patients admitted to intensive care after severe trauma, or presenting with acute respiratory distress, or undergoing cardiac, vascular, or digestive surgery with planned postoperative intensive care. Exclusion Criteria Exclusion Criteria: * Expressed opposition from the patient, a relative (if applicable), or their legal representative (guardian, curator) * Pregnant woman * Hemoglobin less than 7g/dl at inclusion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06549374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06549374 currently recruiting?
Yes, NCT06549374 is actively recruiting participants. Contact the research team at jean-michel.constantin@aphp.fr for enrollment information.
Where is the NCT06549374 trial being conducted?
This trial is being conducted at Annecy, France, Clermont-Ferrand, France, Lyon, France, Paris, France and 3 additional locations.
Who is sponsoring the NCT06549374 clinical trial?
NCT06549374 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 200 participants.