Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

This study is looking at a new medicine called Immukine, given as an injection, to see if it can help people with a severe blood infection caused by a fungus, called candidemia. This infection can be very serious, and researchers hope Immukine, when given with standard treatments, will improve how quickly patients recover. It's a 'Phase II' study, which means it's still in the earlier stages of testing, focusing on both the safety of the new treatment and how well it works. They will be checking if patients clear the infection faster and how their overall health is affected, including any side effects. This research aims to find better ways to treat this important infection.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

125

Start

08 Nov 2024

Candidemia

What is this study about?

Imagine your body is fighting off an infection, but this time it's caused by a type of yeast called Candida, and it's spread into your bloodstream. This serious condition is called candidemia. Doctors usually treat it with other medicines, but sometimes these aren't enough, or people don't get better as quickly as hoped.

This study is testing a new medicine called Immukine. It's an injection that might help your body's immune system fight the infection better. Researchers want to see if adding Immukine to the usual treatment helps clear the infection faster and if it's safe to use. They'll be watching closely to see how patients respond.

During the study, doctors will be checking various things. The main goal is to see how long it takes for the fungus to disappear from the blood. They will also look at how quickly other symptoms of the infection improve, if there are any side effects, and generally how people feel over time. This kind of research is really important because it helps scientists find new and better ways to treat serious illnesses like candidemia.

Key takeaways

It's about a new injection (Immukine) for a serious blood infection (candidemia).
It aims to see if Immukine helps clear the infection faster and is safe.
Participation involves receiving Immukine alongside usual care and having regular check-ups.
This is an early-stage study (Phase II) looking for better treatment options.
Both men and women aged 18 and over can potentially take part if they have candidemia.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit, so adults of all ages are welcome.

Both men and women can participate in this research. The study is specifically for people who have been diagnosed with Candidemia, which is a blood infection caused by a type of yeast called Candida.

Before you can join, the study team will carefully check to make sure the study is right for you and that you meet all the health requirements. This is to keep you safe and make sure the study results are as clear as possible.

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 old or older?
Do you have a bloodstream infection called candidemia?
Are you able to receive injections?
Are you willing to have regular blood tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Immukine, which is given as an injection, in addition to the standard treatments you would already be getting for your candidemia. The researchers will be particularly interested in how quickly your blood tests show no signs of the fungal infection. You will have regular blood tests to check this, as well as to look at your overall health and how your body is responding to the treatment.

Doctors will also be monitoring how well your infection is clearing up, checking for any side effects, and looking at how you feel generally. This involves assessments like checking your organ function and nutritional status. You may also be asked to provide samples for more in-depth tests like genetics and to look at the bacteria in your gut. These assessments will happen at different points during and after your treatment, including until around 28 days after your main treatment ends. The total duration of your participation will depend on how long your treatment lasts and how long the follow-up period is.

Potential risks and benefits

Taking part in this study might offer the potential benefit of a new treatment that could help clear your candidemia infection more quickly than standard care alone. However, like all medicines, Immukine could have side effects, which the study team will explain to you and monitor carefully. There's also no guarantee that the new treatment will work for everyone, as this is still a research study. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Greece
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Unverified
Romania
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Unverified
Germany

Common questions

What is candidemia?

Candidemia is a serious bloodstream infection caused by a type of yeast called Candida.

What is Immukine?

Immukine is a new medicine, given as an injection, being tested to help the body fight the Candida infection.

Why is this study being done?

This study aims to find out if adding Immukine to standard treatment helps people with candidemia recover faster and if it's safe.

Who can join the study?

Adults aged 18 years or older, both men and women, who have candidemia can potentially join.

Will I still get my usual treatment?

Yes, Immukine will be given in addition to the standard treatments you would normally receive for candidemia.