RecruitingNAINTERVENTIONAL

Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)

Organ transplant patients can get a common virus called Cytomegalovirus (CMV). While CMV infection is often mild, sometimes it can be serious. Doctors currently use blood tests to spot CMV, but it's not always clear if treatment is needed right away. This study is testing a new blood test called QuantiFERON-CMV (Q-CMV). This test checks how well a patient's immune system is fighting the virus. The goal is to see if knowing the Q-CMV test result can help doctors decide which patients with CMV infection can safely delay or avoid antiviral medicines, which can have side effects. This could mean fewer unnecessary treatments for transplant patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

288

Start

24 Sep 2024

Estimated completion

01 Oct 2026

Cytomegalovirus Infections Heart Transplantation Kidney Transplantation Lung Transplantation Liver Transplantation

What is this study about?

When you have an organ transplant, taking medicines to stop your body from rejecting the new organ can sometimes weaken your immune system. This makes you more likely to get infections, and one common infection is from a virus called Cytomegalovirus, or CMV. While many people carry CMV without symptoms, in transplant patients, it can sometimes cause problems. Doctors regularly check for CMV in your blood, but often, the virus is detected when you feel fine and aren't showing any symptoms of illness.

Currently, if CMV is found in your blood, doctors might suggest antiviral medicines. However, these medicines can have side effects. Not everyone who has CMV detected in their blood goes on to develop serious illness; some people's immune systems can handle it without medication. This study is looking for a better way to figure out who really needs treatment and who might not.

The study focuses on a specific blood test called QuantiFERON-CMV (Q-CMV). This test looks at how well your body's infection-fighting cells, called T-cells, are reacting to the CMV virus. The idea is that if your T-cells are responding well, your body might be able to control the virus on its own, meaning you might not need antiviral medicine. This research aims to see if giving doctors this Q-CMV test result helps them make more informed decisions about treating CMV infection, potentially reducing the need for unnecessary antiviral drugs and their side effects.

Key takeaways

Study for organ transplant patients with CMV detected in blood.
Aims to see if a new test (Q-CMV) can guide treatment decisions.
Could help avoid unnecessary antiviral medicines and side effects.
Participation involves extra blood tests and close monitoring.
Involves heart, kidney, liver, and lung transplant recipients.
Your standard medical care will continue throughout the study.

Who may be eligible?

This study is looking for adult patients who have had a heart, kidney, liver, or lung transplant. You would be considered if a blood test shows you have CMV infection, but you are not experiencing any symptoms like fever or organ damage. The amount of CMV in your blood also needs to be within a specific range for you to be eligible.

Also, your CMV infection should have appeared within two years of your transplant, or within two years of stopping any preventative anti-CMV medicine you might have been taking after your transplant. You must be at least 18 years old and able to provide informed consent, meaning you understand the study and agree to take part.

There are some reasons you wouldn't be able to join. For example, if you are already taking certain antiviral medicines for herpes viruses, or if you are pregnant or breastfeeding. Also, if you are under legal guardianship or cannot be easily contacted in an emergency, you wouldn't be able to participate.

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.

Are you 18 years or older?
Have you had a heart, kidney, liver, or lung transplant?
Do you currently have CMV detected in your blood, but no symptoms?
Was your CMV infection found within two years of your transplant or stopping preventative medicine?
Are you NOT currently taking specific antiviral medicines for herpes viruses?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a blood test for the new QuantiFERON-CMV (Q-CMV) test. Then, you'll be put into one of two groups by chance. For one group, your doctor will receive the Q-CMV test result to help them decide on your treatment. For the other group, your doctor will decide on treatment based on standard practice without knowing the Q-CMV result.

Regardless of the group you are in, your doctors will routinely monitor your CMV levels and other health markers through additional blood tests. These follow-up blood tests will happen about 5 to 12 days after your initial Q-CMV test, then again about 7 to 14 days later, and a final time about 7 to 14 days after that. The total duration of your active participation will involve these three follow-up checks, spanning approximately 19 to 40 days following your initial Q-CMV test.

Potential risks and benefits

Potential downsides of participating might include the inconvenience of extra blood tests. There's also a chance that, depending on which group you're in, your treatment decisions might be influenced by a test that is still being evaluated, potentially leading to delayed treatment for CMV if the test is misleading (though your doctors will be closely monitoring you). The main potential benefit is that if the study shows this test is effective, it could help many transplant patients in the future avoid unnecessary antiviral medications and their side effects. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU Grenoble Alpes
Verified postcode
Grenoble, France· Recruiting

Common questions

What is CMV infection?

CMV (Cytomegalovirus) is a common virus. In organ transplant patients, whose immune systems are often weaker, it can sometimes cause health problems. Doctors check for it with blood tests.

What is the QuantiFERON-CMV test?

It's a new blood test that looks at how well your body's immune cells are responding to the CMV virus. It helps doctors understand if your immune system might be able to fight the infection on its own.

Why is this study important?

It aims to help doctors decide whether organ transplant patients with CMV infection truly need antiviral medicine, or if they can safely avoid it, reducing unnecessary side effects.

Will I still get my usual medical care?

Yes, regardless of your participation in the study, you will continue to receive the standard medical care needed for your transplant and any infections.

What happens if I don't want to participate?

Your decision not to participate will not affect your medical care or relationship with your doctors in any way.

How to find out more

Olivier Epaulard, MD, PhD

oepaulard@chu-grenoble.fr 0476765291 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.