Can a drug with the potential to boost the immune system (interferon gamma) prevent infection in patients who are critically ill and at particularly high risk of developing new infections during their stay in an intensive care unit?
When someone becomes severely unwell and needs intensive care, their body's natural defences can become exhausted or 'stunned'. This leaves them at high risk of catching new hospital infections. Doctors frequently use antibiotics to treat these bugs, but overuse can create dangerous drug-resistant bacteria. The INFINIT study is testing a drug called interferon gamma. Researchers want to see if this medicine can safely kickstart the immune system in vulnerable intensive care patients. Adults on breathing machines or organ support whose blood tests show a weakened immune system may be eligible. Taking part involves having three small injections under the skin over seven days. Half of the participants will receive the active medicine, while the other half receive a dummy injection (placebo). Because patients are already monitored around the clock in intensive care, doctors will closely track their safety and see whether the treatment helps reduce infections.
At a glance
What is this study about?
Being admitted to an intensive care unit (ICU) means a person is facing a life-threatening illness or injury. What many people do not know is that severe illness can temporarily shut down or 'stun' the body's immune system. When immune cells cannot work properly, patients become easy targets for new bugs and infections that develop inside the hospital. These secondary infections can slow down recovery and lead to serious complications.
Doctors currently rely on antibiotics to treat these infections. However, using large amounts of antibiotics can encourage bacteria to become resistant, creating hard-to-treat 'superbugs'. Doctors at Newcastle University are testing a different approach using a medicine called interferon gamma. Instead of attacking bacteria directly like an antibiotic, interferon gamma acts like a wake-up call for the body's own immune cells, helping them regain their strength to destroy germs on their own.
This clinical study, funded by the Medical Research Council, aims to find out whether giving three doses of interferon gamma is safe and whether it can prevent new infections from developing in high-risk ICU patients. If successful, this research could offer an important new tool to protect critically ill patients, improve survival rates, and reduce reliance on antibiotics in intensive care units across the UK.
Key takeaways
- The INFINIT trial explores whether an immune-boosting drug can prevent hospital infections in ICU patients.
- The study targets adults in intensive care on breathing machines or complex organ support.
- Participants receive three small injections under the skin over seven days.
- Patients are randomly assigned to receive either the active medicine or a dummy injection (placebo).
- All care takes place in the intensive care unit with 24-hour medical monitoring and no extra hospital visits.
Who may be eligible?
This study is open to adults aged 18 and older who are receiving treatment in an intensive care unit (ICU) in the UK. To be considered, a patient must have been in the ICU for at least two days and need substantial organ support. This means they are either breathing with the help of a mechanical ventilator or receiving specialised support for both their blood pressure and their kidneys. Doctors also carry out a specific blood test to confirm that the patient's immune system is temporarily weakened.
Because patients in intensive care are often asleep, sedated, or too unwell to give informed consent themselves, a family member, partner, or nominated legal representative can give permission on their behalf.
Not everyone in intensive care can join. Patients cannot take part if they are pregnant or breastfeeding, have severe chronic liver disease, a history of active epilepsy, or certain serious heart problems. The trial is also not suitable for people who have had an organ transplant, those receiving chemotherapy or immunotherapy for cancer, or anyone known to be allergic to interferon medicines or latex.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Aged 18 or older and currently staying in a UK intensive care unit (ICU).
- Has been cared for in the ICU for at least 48 hours.
- Needs a ventilator machine to breathe, or needs help for both blood pressure and kidney function.
- Blood test confirms a weakened immune defence system.
- Not pregnant or breastfeeding.
- No history of organ transplant, active cancer chemotherapy, or severe liver disease.
What does participation involve?
Participants are chosen at random by a computer to join one of two groups. One group receives the active medicine (interferon gamma), while the other receives an inactive salt-water injection (placebo). To keep the test fair, neither the patient, their family, nor the treating doctors will know which treatment is given until the trial finishes.
Taking part involves having three small injections just under the skin across a seven-day period. Because participants are already staying in the ICU, there are no extra appointments or hospital visits to attend. The medical team will take small blood samples to check immune levels and safety, but these will almost always be taken through the drips and lines the patient already has in place, avoiding extra needle pricks. Total blood taken for each test will be less than two tablespoons. The ICU team continuously monitors the patient throughout their stay.
Potential risks and benefits
Locations (13)
- Sunderland Royal HospitalApproximateSunderland, England
- Freeman HospitalApproximateNewcastle upon Tyne, England
- AddenbrookesApproximateCambridge, England
- The Royal Victoria HospitalCity onlyBelfast, Northern Ireland
- Royal Oldham HospitalApproximateOldham, England
- Wythenshawe HospitalUnverifiedManchester, England
- Chelsea and Westminster HospitalUnverifiedLondon, England
- University Hospital BirminghamUnverifiedBirmingham, England
- Aintree University HospitalUnverifiedLiverpool, England
- Royal Liverpool University HospitalUnverifiedLiverpool, England
- Royal Victoria InfirmaryUnverifiedNewcastle upon Tyne, England
- Manchester Royal InfirmaryUnverifiedManchester, England
Common questions
Why is a placebo used in this study?
A placebo looks identical to the real drug but contains no active medicine. Comparing the two groups allows researchers to clearly see whether health improvements or side effects are truly caused by the study medicine.
How can my relative join if they are unconscious or sedated?
UK law allows a close family member, partner, or an appointed independent doctor to act as a legal representative. They can give permission for the patient to join until the patient is well enough to make their own decisions.
Will taking part cause extra pain or needle pricks?
Doctors take study blood samples from existing lines and drips that are already in place for regular ICU care. The study injections are given under the skin, and ICU patients routinely receive pain relief as part of their standard care.
What happens if a side effect occurs?
Patients in intensive care are checked continuously. Daily blood tests check liver health, and an independent safety committee oversees the trial. If any concerning reaction occurs, the study treatment will be paused or stopped immediately.
Does it cost anything to be part of the trial?
No. The trial is funded by the Medical Research Council and run through the NHS. There are no costs for the medication, tests, or participation.
How to find out more
Jaki Hodgson
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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