A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin followed by Oral Ibrexafungerp versus Intravenous Echinocandin followed by Oral Fluconazole (MARIO)
This study is called MARIO and investigates new ways to treat serious fungal infections in the bloodstream or organs, known as candidemia and invasive candidiasis. Participants will first receive a standard antifungal given through a drip. Then, half will switch to an experimental tablet called ibrexafungerp, and the other half will receive an established tablet called fluconazole. This helps researchers compare the effectiveness and safety of ibrexafungerp against a known treatment. The main goal is to see how many people are still alive and well 30 days after starting the treatment and if the infection clears up successfully.
At a glance
What is this study about?
This research study, called MARIO, is looking into better ways to treat a serious type of fungal infection. These infections, known as candidemia or invasive candidiasis, can affect your bloodstream or internal organs and can be very serious. Currently, doctors often use a drip treatment first, followed by another medicine in tablet form. This study wants to see if a newer tablet, called ibrexafungerp, works as well as or better than a commonly used tablet called fluconazole after that initial drip treatment.
Imagine you have a bad fungal infection. You would first get a powerful antifungal medicine through a drip. After this initial treatment, the study would then randomly assign you to one of two groups. One group would receive the new ibrexafungerp tablets, and the other group would receive fluconazole tablets, which is a well-known antifungal medicine. Neither you nor your doctor would know which tablet you are getting, which helps make the study fair and unbiased.
The main aim of the study is to find out which treatment helps people recover best and if the infection clears up. Researchers will be checking how many people are still alive after 30 days and how well the infection has responded to the treatment. They will also keep a close eye on any side effects to make sure the treatments are safe.
Key takeaways
- This study compares a new tablet (ibrexafungerp) with a standard one (fluconazole) for serious fungal infections.
- Initial treatment will be given through a drip, followed by one of the study tablets.
- Neither you nor your doctor will know which tablet you are taking.
- Researchers will check how well the treatment works and any side effects.
- The main focus is on survival after 30 days and successful infection clearance.
- You must be 18 or older with a diagnosed candidemia or invasive candidiasis.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. Both men and women can take part. The most important thing is that you have been diagnosed with a serious fungal infection called candidemia or invasive candidiasis.
There might be other health conditions or medicines that would prevent you from joining, as the researchers need to make sure the study is safe for everyone involved and that the results are clear. Your doctor will carefully review all your health information to see if this study is suitable for you.
This study is for adults who are dealing with a severe fungal infection and who meet specific health criteria set by the researchers. It's important to discuss your full medical history with your doctor to understand if you qualify.
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?
- Have you been diagnosed with candidemia or invasive candidiasis?
- Are you comfortable potentially receiving either a new or standard treatment?
- Are you able to attend regular clinic visits and take medication?
- Are you willing to have regular blood tests and check-ups?
What does participation involve?
If you decide to take part in this study, you would first receive a standard antifungal medicine through a drip. After this, you would then be given either the new study medicine (ibrexafungerp tablets) or a standard medicine (fluconazole tablets) to take by mouth. You would not know which medicine you are receiving, nor would your doctor.
Throughout the study, you would have regular visits to the clinic. These visits would involve check-ups to see how you are feeling, blood tests to monitor the infection and your overall health, and possibly other tests like scans if needed. Researchers will also ask you about any side effects you might experience. The total length of your participation would depend on how long your treatment lasts and how long the doctors need to follow up on your recovery, potentially for several weeks after your main treatment finishes.
Potential risks and benefits
Locations (7)
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- —UnverifiedItaly
Common questions
What is candidemia or invasive candidiasis?
These are serious infections caused by a type of yeast called Candida, which can get into your bloodstream or organs and make you very ill.
What does 'double-blind' mean?
It means neither you nor your doctor will know whether you are getting the new medicine or the standard medicine, helping to keep the study fair.
Why are different medicines given?
Patients will first get a medicine through a drip, and then switch to a tablet. This study is comparing two different tablets to see which is more effective and safer after the initial drip treatment.
What is the main goal of the study?
The main goal is to see how many people are alive and well 30 days after starting treatment and if the infection successfully clears up.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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