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

Study acronym: PLATINIUM
StatusRecruiting
PhasePhase 3
Started2025-07-09
View on ClinicalTrials.gov ↗

Amendment history

2025-11-19
Study Status, Contacts/Locations v3
Study sitesdetails revised at 18 of 23 sites
2025-09-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-10-01→2028-10-09
Completion date2028-10-01→2028-10-09
Start dateestimated 2025-07-01→confirmed 2025-07-09
Study sitesdetails revised at 23 of 23 sites
2025-05-07
Study Status, Oversight, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2028-09-01→2028-10-01
Completion date2028-09-01→2028-10-01
Start date2025-06-01→2025-07-01
Study sites22→23
Eligibility criteria+1,255 characters
[...] east 1 week Expected length of stay in the ICU greater than 110 weekdays at screening At least 1 episode of multiple organ failure, [...] and a lymphopenia < 1000/mm3 within a 96 hours time window Consent from family membersPatient or patientthe 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 contr [...] [...]
Secondary endpoints11 entries, revised
Rate of serious adverse effectsreactions and suspected unexpected serious adverse reaction (SUSAR)
2025-01-13
Original filing
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 Details
NCT Number NCT06774235
Lead Sponsor University Hospital, Limoges
Conditions Sustained Immunosuppression
Enrollment 326 participants
Start Date 2025-07-09
Primary Completion 2028-10-09 (estimated)
Study Completion 2028-10-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-20