Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo

NCT06694740 | Recruiting Phase 2 DMC

• 2 other identifiers: APHP2206722023-506725-11-00
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief Summary

The vast majority of serious clinical situations leading to intensive care (septic shock, polytrauma, acute cerebral aggression, major surgery) are characterized by significant systemic inflammation. Recently, the existence of a common immune response pattern to acute aggression has been demonstrated, and with it the existence of a phenomenon known as post-aggressive immunosuppression (PAIS).

Conditions

Adult Under Mechanical Ventilation, and Presenting an mHLA-DR Less Than 8,000AB/C; Post-aggressive Immunosuppression; Adult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6

Keywords

Critical care; ICU-acquired immune suppression; HLA-DR; immunity; sepsis

Outcome Measures

Primary Outcomes (1)

• number of days alive without mechanical ventilation

  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

  on Day 28 after drug administration

Secondary Outcomes (9)

• 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

  Day 1 to Day 7 and at Day 28 post randomization

• Evaluate, depending on the randomization arm, the kinetics of plasma inflammatory parameters between patients treated with recombinant interferon gamma 1-b versus placebo

  Day 0, Day 3 and at Day 7 post randomization

• mortality at Day 28 and Day 90 after randomization

  Day 28 and Day 90 after randomization

• incidence of nosocomial infections during intensive care unit stay

  from Day 0 to Day 28 (or the discharge from intensive care)

• number of days alive whithout antibiotic

  Day 28 after drug administration

Study Arms (2)

interferon gamma-1b injection

EXPERIMENTAL

Patients randomized to the experimental arm will receive : Recombinant human interferon gamma-1b 2 X 106 IU, injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Placebo injection

PLACEBO COMPARATOR

Patients randomized to the placebo arm will receive saline injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Drug: Placebo

Interventions

Interferon Gamma 1-b DRUG

interferon gamma-1b 2 X 106 IU, injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Placebo DRUG

Patients randomized to the placebo arm will receive saline injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Placebo injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old
• SOFA score for first 24 hours post-admission ≥ 6
• mHLA-DR\< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit
• Patient affiliated to a social security scheme
• Written consent (relative/trusted person)

You may not qualify if:

• Patient with estimated life expectancy of less than 3 months
• Patients with a predicted remaining stay in intensive care \< 72 hours
• 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
• 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
• Pregnant or breast-feeding women
• Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)
• Patients on immunosuppressive therapy, including long-term corticosteroid therapy (\>2.5mg/d prednisone equivalent)
• Patients with severe hepatic or renal insufficiency
• Patient included in another interventional clinical trial
• People under court protection and protected adults

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Dr de Roquetaillade

Paris, France

RECRUITING

Pr Dépret

Paris, France

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Officials

• Charles De ROQUETAILLADE, MD

  APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

  STUDY CHAIR

Central Study Contacts

Charles De ROQUETAILLADE, MD

CONTACT

01 49 95 55 68; charles.de-roquetaillade@aphp.fr

Benjamin CHOUSTERMAN, Professor

CONTACT

01 49 95 85 18; benjamin.chousterman@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 19, 2024
• Study Start: January 12, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (2)