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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges

About this 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:

* 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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Interferon Gamma 1-b
  • Placebo

Treatment groups

326 Participants
are divided into 2 treatment groups

Sponsors and collaborators