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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

24 Feb 2026 → ongoing

Decision date (initial)

2024-10-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506725-11-00

ClinicalTrials.gov

NCT06694740

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the efficacy of subcutaneous administration of recombinant human interferon gamma 1-b (IFNy) in improving the number of days alive without mechanical ventilation at D28(or when leaving intensive care) compared with a placebo in patients admitted to intensive care, with a high severity score (SOFA of the first 24 hours post-admission ≥ 6) and a biological criterion of immunosuppression (mHLA-DR < 8000 AB/C) measured between days 5 and 10 of their admission to intensive care.

Secondary objectives 7

1. Evaluate the efficacy of IFNy in correcting PAIS-defining biological abnormalities (re-ascension of mHLA-DR above 8,000 AB/C) between patients treated with recombinant interferon gamma 1-b versus placebo
2. Evaluate, depending on the randomization arm, the kinetics of plasma inflammatory parameters and leucocyte count between patients treated with recombinant interferon gamma 1-b versus placebo
3. Compare mortality at D28 and D90 of randomization between patients treated with recombinant interferon gamma 1-b versus placebo
4. Compare the incidence of nosocomial infections during ICU stay defined according to the criteria of the International Sepsis Forum Consensus Conference between patients treated with recombinant interferon gamma 1-b versus placebo
5. Compare the number of days alive whithout antibiotic at D28 of randomization between patients treated with recombinant interferon gamma 1-b versus placebo
6. Comparing length of stay in intensive care between patients treated with recombinant interferon gamma 1-b versus placebo
7. Compare organ failure score (SOFA) kinetics between patients treated with recombinant interferon gamma 1-b versus placebo

Conditions and MedDRA coding

Post-aggressive immunosuppression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient ≥ 18 years old
2. SOFA score for first 24 hours post-admission ≥ 6
3. Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded)
4. mHLA-DR< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit
5. Patient affiliated to a social security scheme
6. Written consent (relative/trusted person)

Exclusion criteria 10

1. Patient with estimated life expectancy of less than 3 months
2. Patients with a predicted remaining stay in intensive care < 72 hours
3. Patient with pre-existing immunosuppression: solid cancer active or in remission for < 5 years, active hemopathy or in remission for < 5 years, systemic disease (including in the absence of specific treatment), solid organ transplant or marrow allograft patient, patient suffering from a HIV infection
4. Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow score < 8, patient resuscitated from an arterial stroke,) patients with tracheotomy for ENT problems, patients suffering from muscular disease (e.g. myopathy), patients on long-term mechanical ventilation
5. Pregnant or breast-feeding women
6. Patients on immunosuppressive therapy, including long-term corticosteroid therapy (>2.5mg/d prednisone equivalent)
7. Patients with severe hepatic or renal insufficiency
8. Patient included in another interventional clinical trial
9. Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)
10. People under court protection and protected adults

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 9

1. 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
2. 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.
3. Mortality rate at D28 and D90 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo
4. The incidence of nosocomial infections during an ICU stay between patients treated with recombinant interferon gamma 1-b versus placebo
5. Number of days alive without antibiotic assessed on day 28 after randomization between patients treated with recombinant interferon gamma 1-b versus placebo
6. Number of antibiotic-free days at 28 days after randomization
7. 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
8. 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.
9. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Charles de ROQUETAILLADE

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Charles de ROQUETAILLADE

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications