AzTrials
AzTrials

Sustained ImmunosuppressionPhase 3PLATINIUMNCT06774235

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

A Phase 3 study testing Interferon Gamma 1-b in people with Sustained Immunosuppression, run by University Hospital, Limoges at 23 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sustained Immunosuppression
What is being tested?
Interferon Gamma 1-b
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
326 participants
Where
23 sitesFrance
Study dates
9 Jul 2025to 9 Oct 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Pregnancy or breast feeding
  • Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon
  • Hepatic cytolysis with AST/ALT > 5 times ULN (local laboratory)
  • Suspected acute pancreatitis with lipase or amylase > 3 times ULN (local laboratory)
  • Severe chronic renal failure (eGFR<10 ml/min/1.73m2 CKP-EPI method)
  • Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)
  • Mental state rendering the person giving consent incapable of understanding the trial
  • Patient deprived of liberty by judicial or administrative decision
  • Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

23 sites in 1 country

France23 sites, 23 recruiting

  • Angers university hospial

    Angers, 49100

    Pierre ASFAR, MD, +33241353815, pierre.asfar@univ-angers.fr

    Pierre ASFAR, MD

    Recruiting

  • Argenteuil hospital

    Argenteuil, 95107

    Gaetan PLANTEFEVE, MD, +33134231445, gaetan.plantefeve@ch-argenteuil.fr

    gaetan PLANTEFEVE, MD

    Recruiting

  • Franche-comté north Hospital

    Belfort, 90015

    Julio BADIE, MD, +33384981970, Julio.BADIE@hnfc.fr

    julio BADIE, MD

    Recruiting

  • Brive Hospital

    Brive-la-Gaillarde, 19100

    Nicolas PICHON, MD, +33555926013, nicolas.pichon@ch-brive.fr

    Nicolas PICHON, MD

    Recruiting

  • Chalon sur saone Hospital

    Chalon-sur-Saône, 71100

    Thomas MALDINEY, MD, +33385910111, thomas.maldiney@ch-chalon71.fr

    Thomas MALDINEY, MD

    Recruiting

  • Dijon University Hospital

    Dijon, 21000

    Jean-Pierre QUENOT, MD, +33380293685, jean-pierre.quenot@chu-dijon.fr

    Jean-Pierre QUENOT, MD

    Recruiting

  • APHP - Raymond Poincaré

    Garches, 92380

    Djillali ANNANE, MD, +33147107787, djillali.annane@rpc.aphp.fr

    Djillali ANNANE, MD

    Recruiting

  • Versailles Hospital

    Le Chesnay, 78157

    Stéphane LEGRIEL, MD, +33139639717, slegriel@ch-versailles.fr

    Stéphane LEGRIEL, MD

    Recruiting

  • Le mans Hospital

    Le Mans, 72000

    Christophe GUITTON, MD, cguitton@ch-lemans.fr

    Christophe GUITTON, MD

    Recruiting

  • CH de Lens

    Lens, 62300

    Nicolas VAN GRUNDEBEECK, MD, 0321691088 ext. +33, nvangrunderbeeck@ch-lens.fr

    Nicolas VAN GRUNDERBEECK, MD

    Recruiting

  • Limoges University Hospital

    Limoges, 87042

    Bruno FRANCOIS, MD, 0555058841 ext. +33, bruno.francois@chu-limoges.fr

    Bruno Francois, MD

    Recruiting

  • Lyon Civils Hospices

    Lyon, 69002

    Anne-Claire LUKASZEWICZ, MD, +33472111327, anne-claire.lukaszewicz@chu-lyon.fr

    Anne-Claire LUKASZEWICH, MD

    Not yet recruiting

  • APHM

    Marseille, 13915

    Sami HRAIECH, MD, +33491965836, sami.hraiech@ap-hm.fr

    Sami HRAIECH, MD

    Recruiting

  • Melun Hospital

    Melun, 77000

    Mehran MONCHI, MD, +33181742258, mehran.monchi@ghsif.fr

    Mehran MONCHI, MD

    Recruiting

  • Nancy University Hospital

    Nancy, 54035

    Sébastien GIBOT, MD, +33383852123, s.gibot@chru-nancy.fr

    Sébastien GIBOT, MD

    Recruiting

  • Nantes University Hospital

    Nantes, 44000

    Antoine ROQUILLY, MD, +33240582230, antoine.roquilly@chu-nantes.fr

    Antoine ROQUILLY, MD

    Recruiting

  • Orléans Hospital

    Orléans, 45100

    François BARBIER, MD, +33238514446, francois.barbier@chr-orleans.fr

    François BARBIER, MD

    Recruiting

  • APHP - Laroiboisière

    Paris, 75010

    Nicolas DEYE, MD, +33149956347, nicolas.deye@lrb.aphp.fr

    nicolas DEYE, MD

    Recruiting

  • Aphp - Hegp

    Paris, 75014

    Jean-Luc DIEHL, MD, +33156093204, jean-luc.diehl@aphp.fr

    Jean-Lus DIEHL, MD

    Recruiting

  • APHP - Cochin

    Paris, 75015

    Jean-Paul MIRA, MD, +33158412501, jean-paul.mira@aphp.fr

    Jean-Paul MIRA, MD

    Recruiting

  • Rennes University Hospital

    Rennes, 35000

    Jean-Marc TADIE, MD, +33299284248, jeanmarc.tadie@chu-rennes.fr

    Jean-Marc TADIE, MD

    Recruiting

  • Strasbourg University Hospital

    Strasbourg, 67091

    Louise-Marie JANDEAUX, MD, +33369551212, Louise-marie.jandeaux@chru-strasbourg.fr

    Louise-Marie JANDEAUX, MD

    Recruiting

  • Tours University Hospital

    Tours, 37000

    Antoine GUILLON, MD, +33139639717, antoine.guillon@univ-tours.fr

    Antoine GUILLON, MD

    Recruiting

Other trials in France

About this study

Official title: Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial

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:

Read more
  • 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
Being tested
Interferon Gamma 1-b, Placebo
Keywords
ICU, Immuno-restauration, Secondary infections, Prevention
Medical subject headings
Coinfection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon Gamma 1-bDrug

    injection of interferon gamma 1-b

  • PlaceboDrug

    Injection of placebo in the same condition of experimental traitment

Study groups in NCT06774235
Study groupRoleWhat they receive
Interferon-gammaExperimentalInjections 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
Receives: Drug: Interferon Gamma 1-b
PlaceboPlacebo comparatorThe comparative treatment will be a placebo, consisting in 0.5 ml of 0.9% sodium chloride solution only (same volume for interferon gamma-1b)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 90

Secondary outcomes (11)

  1. Cause of mortality of participant

    All-cause ICU mortality and at Day 90

    Measured: Day 90

  2. Length of stay in the ICU and in the hospital

    Number of days spent in the ICU and in the hospital at Day 90

    Measured: Day 90

  3. Antibiotic consumption

    Name of antibiotics taken at Day 90

    Measured: Day 90

  4. Biological immune restoration

    Percentage of biological immune restoration (defined as an HLA-DR > 13 500 Ab/c [Antibodies bound per cell] and an absolute lymphocyte count > 1200 mm3) at Day 10

    Measured: Day 10

  5. Healthcare costs

    Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance

    Measured: Day 90

  6. Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR)

    Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90 according to sponsor causality assessment

    Measured: Day 90

  7. Antifungal consumption

    Name of antifungals taken at Day 90

    Measured: Day 90

  8. Antifungal consumption

    Dosage of antifungals taken at Day 90

    Measured: Day 90

  9. Antifungal consumption

    Duration of antifungals taken at Day 90

    Measured: Day 90

  10. Antibiotic consumption

    Dosage of antibiotics taken at Day 90

    Measured: Day 90

  11. Antibiotic consumption

    Duration of antibiotics taken at Day 90

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start9 Jul 2025
  3. Primary completion9 Oct 2028 (estimated)
  4. Study completion9 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
326 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06774235
Sponsor's protocol ID
87RI24_0040 (PLATINIUM)
Other IDs
2024-516780-93-00
Acronym
PLATINIUM
Status last verified
Nov 2025
First submitted
6 Jan 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41592843

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon Gamma 1-b in people with Sustained Immunosuppression, run by University Hospital, Limoges at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of secondary infection episodes (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06774235, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in