Prevention of secondary infections by interferon gamma in ICU-acquired sustained immune-suppression: a randomized trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Et Universitaire De Limoges

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

9 Jul 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS

External identifiers

EU CT number

2024-516780-93-00

WHO UTN

U1111-1316-9857

ClinicalTrials.gov

NCT06774235

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To demonstrate the benefit of a standardized immunotherapy with IFN-γ versus placebo on the incidence of secondary infections at three months (Day 90) in ICU patients with documented sustained immunosuppression.

Secondary objectives 6

1. Reduction of ICU and Day-90 mortality
2. Reduction of ICU and hospital length of stay
3. Reduction of antibiotic and antifungal consumption at Day 90
4. Biological immune restoration at Day 10
5. Cost-consequence and cost-effectiveness analyses
6. To describe safety of Interferon gamma-1b

Conditions and MedDRA coding

Sustained immunosuppression

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Adult patient hospitalized in the ICU for at least 1week
2. Expected length of stay in the ICU greater than 10 days at screening
3. 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 weeks of ICU hospitalization
4. Immunosuppression defined as an HLA-DR < 8000 Ab/c and a lymphopenia < 1000/mm3 within a 96 hours time window
5. Patient or the legal representative giving consent must be able to understand the trial in its entirety
6. Patient affiliated to the social security system
7. For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90
8. For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90.

Exclusion criteria 24

1. Uncontrolled secondary infections ongoing at the time of screening
2. Severe chronic renal failure (eGFR<10 ml/min/1.73m2 CKP-EPI method)
3. Patients under legal protection
4. History of or ongoing tuberculosis
5. Chronic hepatitis B
6. 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 ( see appendix 1)
7. Pregnancy or breast feeding
8. 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
9. Participation in another research clinical trial within 30 days
10. Chemotherapy / radiation therapy within the last 6 weeks
11. Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…)
12. Apache II ≥ 30
13. Mental state rendering the person giving consent incapable of understanding the trial
14. Patient deprived of liberty by judicial or administrative decision
15. 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
16. History of autoimmune disease
17. Organ or bone marrow transplant
18. History of hematologic malignancy
19. History of hepatitis C
20. HIV stage C within the last 12 months
21. Hepatic cytolysis with AST/ALT > 5 times ULN (local laboratory)
22. Suspected acute pancreatitis with lipase or amylase > 3 times ULN (local laboratory)
23. Patient with thrombocytopenia below 50,000/mm3
24. Patient with traumatic brain and spinal injury

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)

Secondary endpoints 6

1. All-cause ICU mortality and at Day 90
2. Length of stay in the ICU and in the hospital at Day 90
3. Antibiotic and antifungal consumption at Day 90
4. 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
5. Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance
6. Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Et Universitaire De Limoges

Sponsor organisation

Centre Hospitalier Et Universitaire De Limoges

Address

2 Avenue Martin Luther King

City

Limoges

Postcode

87000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Et Universitaire De Limoges

Contact name

Bruno FRANCOIS

Public contact point

Organisation

Centre Hospitalier Et Universitaire De Limoges

Contact name

Renaud MARTIN

Locations

1 EU/EEA country · 23 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 14 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