Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT06774235
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
Sponsor:
University Hospital, Limoges
Organization:
Study Overview
Official Title:
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATINIUM
Brief 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. 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-516780-93-00 | CTIS | None | View |