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INFINITY - Effect of interferon gamma as a treatment for post-aggressive immunosuppression in intensive care units, a randomized Bayesian double-blind controlled trial versus placebo

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506725-11-00
Acronym
APHP220672
Enrollment
170
Registered
2024-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-24

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

Conditions

Post-aggressive immunosuppression

Brief summary

Number of days alive without mechanical ventilation on day 28 after randomization or on discharge from intensive care if this occurs before the 28th day

Detailed description

Evolution and kinetics of mHLA-DR measured at D0, D1, D2, D3, D7 and D28 or at discharge from intensive care if earlier (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo, Evolution and kinetics of inflammation markers (IL-1, IL-2, IL-6, IL-8, TNFa, etc.) measured in plasma at D0, D3 and D7, or at discharge from intensive care if it occurs before (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo., Mortality rate at D28 and D90 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo, The incidence of nosocomial infections during an ICU stay between patients treated with recombinant interferon gamma 1-b versus placebo, Number of days alive without antibiotic assessed on day 28 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo, Number of antibiotic-free days at 28 days after randomization, Kinetics of SOFA score assessed at inclusion and during the 7 days following inclusion between patients treated with recombinant interferon gamma 1-b versus placebo, Evolution and kinetics of lymphocyte count measured on D0, D1, D2, D3, D7 and D28 or upon discharge from intensive care if this occurs earlier (D0 corresponding to the day of inclusion in the study) between patients who received recombinant interferon gamma-1b compared with placebo., Changes in the transcriptome profile of circulating PBMC using scRNAseq analysis measured at D0, D3 and D7 or at discharge from intensive care if earlier.

Interventions

DRUG1 mg)
DRUGsolution injectable
DRUGSODIUM CHLORIDE

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of days alive without mechanical ventilation on day 28 after randomization or on discharge from intensive care if this occurs before the 28th day

Secondary

MeasureTime frame
Evolution and kinetics of mHLA-DR measured at D0, D1, D2, D3, D7 and D28 or at discharge from intensive care if earlier (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo, Evolution and kinetics of inflammation markers (IL-1, IL-2, IL-6, IL-8, TNFa, etc.) measured in plasma at D0, D3 and D7, or at discharge from intensive care if it occurs before (D0 corresponding to the day of inclusion in the study) between patients treated with recombinant interferon gamma 1-b versus placebo., Mortality rate at D28 and D90 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo, The incidence of nosocomial infections during an ICU stay between patients treated with recombinant interferon gamma 1-b versus placebo, Number of days alive without antibiotic assessed on day 28 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo, Num

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026