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

Conditions

Sustained immunosuppression

Brief summary

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)

Detailed description

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

Hernandez Padilla AC, Daix T, Hotchkiss RS, Monneret G, Tadie JM, Jeannet R, Plateker O, Vaidie J, Durand-Zaleski I, Magne J, Giraudeau B, François B.

2026-01-27

10.1136/bmjopen-2025-106790

Interventions

DRUGIMUKIN 2 X 106 UI (0

DRUG1 mg)

DRUGsolution injectable

DRUGCHLORURE DE SODIUM 0

DRUG9 % LAVOISIER

DRUGsolution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
All-cause ICU mortality and at Day 90, Length of stay in the ICU and in the hospital at Day 90, Antibiotic and antifungal consumption at Day 90, 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, Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance, Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90	—

Measure

Time frame

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

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Countries

France

Outcome results

None listed