NCT06774235

Brief Summary

The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are: Does Interferon-gamma:

  • reduces the Incidence of secondary infection episodes at three months
  • reduces the ICU mortality and at Day 90
  • reduces the ICU and hospital length of stay
  • induces Biological immune restoration at Day 10
  • has cost-consequence and cost-effectiveness Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression . Participants will:
  • Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9
  • be monitored evety day until their ICU discharge and at day 30, 60 and 90

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
30mo left

Started Jul 2025

Typical duration for phase_3

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jul 2025Oct 2028

First Submitted

Initial submission to the registry

January 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

July 9, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2028

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

January 6, 2025

Last Update Submit

November 19, 2025

Conditions

Sustained Immunosuppression

Keywords

ICUImmuno-restaurationSecondary infectionsPrevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of secondary infection episodes

    Number of episodes divided by the follow-up length, in days, validated by an independent adjudication committee based on the current definitions.

    Day 90

Secondary Outcomes (11)

  • Cause of mortality of participant

    Day 90

  • Length of stay in the ICU and in the hospital

    Day 90

  • Antibiotic consumption

    Day 90

  • Biological immune restoration

    Day 10

  • Healthcare costs

    Day 90

  • +6 more secondary outcomes

Study Arms (2)

Interferon-gamma

EXPERIMENTAL

Injections of Interferon gamma-1b are sub-cutaneous and preferably in the deltoid region left or right or on the anterior part of the thigh. 5 injections between day 1 and day 9

Drug: Interferon Gamma 1-b

Placebo

PLACEBO COMPARATOR

The comparative treatment will be a placebo, consisting in 0.5 ml of 0.9% sodium chloride solution only (same volume for interferon gamma-1b)

Drug: Placebo

Interventions

Interferon Gamma 1-bDRUG

injection of interferon gamma 1-b

Interferon-gamma
PlaceboDRUG

Injection of placebo in the same condition of experimental traitment

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient hospitalized in the ICU for at least 1 week
  • Expected length of stay in the ICU greater than 10 days at screening
  • At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization
  • Immunosuppression defined as an mHLA-DR \< 8000 Ab/c and a lymphopenia \< 1000/mm3 within a 96 hours time window
  • Patient or the legal representative giving consent must be able to understand the trial in its entirety
  • Patient affiliated to the social security system
  • For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90
  • For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.

You may not qualify if:

  • Uncontrolled secondary infections ongoing at the time of screening
  • Participation in another research clinical trial within 30 days
  • Chemotherapy / radiation therapy within the last 6 weeks
  • Apache II ≥ 30 at screening
  • History of autoimmune disease
  • Organ or bone marrow transplant
  • History of hematologic malignancy
  • History of hepatitis C
  • HIV stage C within the last 12 months
  • Patients under legal protection
  • History of or ongoing tuberculosis
  • Chronic hepatitis B
  • Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months
  • Patient with thrombocytopenia below 50,000/mm3
  • Patient with traumatic brain and spinal injury
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Angers university hospial

Angers, 49100, France

RECRUITING

Argenteuil hospital

Argenteuil, 95107, France

RECRUITING

Franche-comté north Hospital

Belfort, 90015, France

RECRUITING

Brive Hospital

Brive-la-Gaillarde, 19100, France

RECRUITING

Chalon sur saone Hospital

Chalon-sur-Saône, 71100, France

RECRUITING

Dijon University Hospital

Dijon, 21000, France

RECRUITING

APHP - Raymond Poincaré

Garches, 92380, France

RECRUITING

Versailles Hospital

Le Chesnay, 78157, France

RECRUITING

Le mans Hospital

Le Mans, 72000, France

RECRUITING

CH de Lens

Lens, 62300, France

RECRUITING

Limoges University Hospital

Limoges, 87042, France

RECRUITING

Lyon Civils Hospices

Lyon, 69002, France

NOT YET RECRUITING

APHM

Marseille, 13915, France

RECRUITING

Melun Hospital

Melun, 77000, France

RECRUITING

Nancy University Hospital

Nancy, 54035, France

RECRUITING

Nantes University Hospital

Nantes, 44000, France

RECRUITING

Orléans Hospital

Orléans, 45100, France

RECRUITING

APHP - Laroiboisière

Paris, 75010, France

RECRUITING

Aphp - Hegp

Paris, 75014, France

RECRUITING

APHP - Cochin

Paris, 75015, France

RECRUITING

Rennes University Hospital

Rennes, 35000, France

RECRUITING

Strasbourg University Hospital

Strasbourg, 67091, France

RECRUITING

Tours University Hospital

Tours, 37000, France

RECRUITING

Related Publications (1)

  • Hernandez Padilla AC, Daix T, Hotchkiss RS, Monneret G, Tadie JM, Jeannet R, Plateker O, Vaidie J, Durand-Zaleski I, Magne J, Giraudeau B, Francois B. Prevention of secondary infections by interferon-gamma in ICU-acquired sustained immune suppression in France: study protocol of the PLATINIUM randomised trial. BMJ Open. 2026 Jan 27;16(1):e106790. doi: 10.1136/bmjopen-2025-106790.

    PMID: 41592843DERIVED

MeSH Terms

Conditions

Coinfection

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
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

January 6, 2025

First Posted

January 14, 2025

Study Start

July 9, 2025

Primary Completion (Estimated)

October 9, 2028

Study Completion (Estimated)

October 9, 2028

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(23)