INFINIT trial - INterFeron to reduce INfection in InTensive care units
Research type
Research Study
Full title
Can interferon gamma prevent infection in critically ill patients at highest risk? A phase II randomised controlled trial - INFINIT (INterFeron to reduce INfection in InTensive care units)
IRAS ID
1006389
Contact name
John Simpson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN10449048
Research summary
Patients admitted to intensive care units (ICUs) are vulnerable to new infections while in ICU. Antibiotics are given to too many patients in the ICU and overuse leads to the emergence of "superbugs" that are resistant to antibiotics. There is a pressing need to prevent infection in the ICU using treatments other than antibiotics.
Severe illnesses "stun" the immune system, leaving immune cells less able to kill bugs. A drug called interferon gamma (IFNg) potentially restores good function to patients' immune cells. This proposal aims to determine whether IFNg is safe, and whether it can reduce antibiotic use and infections, in patients in ICU at greatest risk of developing new infections.
In UK ICUs, patients on a ventilator machine, or who need support to maintain kidney function and blood pressure, and who have a low mHLA-DR (a blood test that indicates greater risk of infection), will enter the study, if consent is granted. Each patient receives an injection under the skin (subcutaneously) once on 3 occasions over the next week. Patients will be allocated at random to one of 4 groups:
Placebo on all 3 occasions
IFNg - 100 microgrammes (mcg) on all 3 occasions
IFNg - 50 mcg on all 3 occasions
IFNg – first dose 100 mcg, but the next 2 doses are either placebo or IFNg 100 mcg, depending on whether mHLA-DR is high or low, respectively.Once 188 patients have entered the study, we shall pause the trial, and analyse results to see which IFNg group had best safety and least antibiotic use, i.e. we "pick the winner", and no more patients will be admitted to the other two IFNg groups. We then resume the trial with only the placebo group and the "winner" IFNg group recruiting another 94 patients. We shall assess whether antibiotic use, death, new infections, length of stay in the ICU, and side effects are significantly less in the "winner" IFNg group than in the placebo group, and whether mHLA-DR goes up more in the "winner" IFNg group.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0295
Date of REC Opinion
23 Oct 2023
REC opinion
Further Information Favourable Opinion