AuthorisedTherapeutic use (Phase IV)Interventional

PTX3 genetically stratified randomized double-blinded allocation event-driven clinical trial for antifungal prophylaxis in patients with acute myeloid leukemia

This study is for adults with a type of blood cancer called acute myeloid leukaemia (AML). When people have AML, their immune system can be weak, making them more likely to get fungal infections. This study is testing different antifungal medicines (like Diflucan and Noxafil) that are given to prevent these infections in the first place. Researchers want to see which medicines are best at stopping these infections over a 6-month period, and if they cause any side effects. It's a 'double-blind' study, meaning neither the patient nor their doctor will know exactly which preventative medicine they are receiving, to ensure fair results.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire Vaudois

Enrolment target

153

Start

16 Oct 2024

Antifungal prophylaxis in patients with acute myeloid leukemia

What is this study about?

This study is designed for individuals who have been diagnosed with acute myeloid leukaemia, often referred to as AML. AML is a serious type of blood cancer that affects white blood cells, which are crucial for fighting off infections. Unfortunately, treatments for AML can weaken the immune system even further, making patients very vulnerable to other illnesses, especially fungal infections. These infections can be quite serious if they're not prevented or treated quickly.

The main goal of this study is to find the best way to stop these fungal infections from happening in the first place. It does this by looking at different antifungal medicines that are already approved and used for this purpose. The study will carefully compare these medicines to see how effective they are at preventing fungal infections over a 6-month period following the start of preventative treatment. It’s important to understand this isn't about testing new, experimental drugs, but rather understanding how best to use medicines that are already available.

Researchers will also be monitoring to see if patients experience any side effects from these preventative medicines, particularly effects on the liver or heart. By comparing the effectiveness and safety of these different treatments, the study aims to provide clearer guidance for doctors on how to protect patients with AML from dangerous fungal infections, ultimately improving their care and health during a very challenging time.

Key takeaways

This study aims to find the best way to prevent fungal infections in people with acute myeloid leukaemia.
It compares different established antifungal medicines already in use.
Participation involves taking a preventative medicine and having regular check-ups for 6 months.
The study helps doctors provide better care and protection for AML patients.
You will be closely monitored for both the effectiveness and any side effects of the medication.

Who may be eligible?

To be part of this study, you must be at least 18 years old. The study is open to both men and women.

More specific details about your health and medical history would be checked by the study team to make sure it's safe and appropriate for you to participate. This might include information about your specific type of leukaemia, other health conditions you have, and any other medications you are currently taking.

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 acute myeloid leukaemia (AML)?
Are you able to attend regular appointments and tests?
Are you willing to take a preventative medication as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of the preventative antifungal medicines. Neither you nor your doctor would know which specific medicine you are getting during the study. You would take this medication as prescribed. The study involves regular check-ups and tests, likely including blood tests, to monitor your health, check for signs of infection, and look for any side effects from the medication. This monitoring would continue for 180 days (about 6 months) from when you start taking the preventative medicine. The total duration of your participation would cover this 6-month period and any follow-up appointments required.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving close monitoring for fungal infections and access to preventative antifungal treatment. The study uses medicines that are already approved, so their safety profiles are generally known. However, like all medications, the antifungal medicines used in this study can have side effects, which might include effects on your liver or heart. The study team will monitor you closely for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
France

Common questions

What is acute myeloid leukaemia (AML)?

AML is a type of cancer that affects the blood and bone marrow, where blood cells are made. It causes the body to make too many abnormal white blood cells.

Why is this study looking at fungal infections?

Treatment for AML can weaken your immune system, making you more prone to common fungal infections that your body would normally fight off. These can be serious.

What does 'antifungal prophylaxis' mean?

It means giving medication to prevent fungal infections from happening, rather than treating them after they've started.

Will I know which medicine I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know which specific antifungal medicine you receive. This ensures the results are fair.

How long will I be in the study?

You will be in the study for 180 days (about 6 months) looking at the effects of the preventative medicine and for any follow-up.