A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species
This study is investigating a new medicine called olorofim for severe fungal infections caused by a type of mould called Aspergillus. These infections can be very serious, especially for people with weakened immune systems. The study aims to find out if olorofim is a better and safer treatment option compared to the current standard medicine, AmBisome. Researchers will carefully compare how well each medicine works and if they cause any side effects. This involves patients being randomly assigned to receive either the new medicine or the standard one. The study is a 'Phase III' trial, which means it's one of the final steps before a new medicine might be approved for wider use. It's an important step in finding better ways to treat these challenging infections.
At a glance
What is this study about?
This research study is focused on a very serious type of infection called 'invasive fungal disease' (IFD), which is caused by a common mould called Aspergillus. These infections can affect many different parts of the body and are particularly dangerous for people whose immune systems are not working well, often because of other illnesses or treatments. Currently, one of the main medicines used for these infections is called AmBisome.
The study aims to see if a new medicine, olorofim, could be a better treatment option. Researchers want to compare olorofim directly with AmBisome to find out if it's more effective at treating the infection and if it has fewer side effects. Finding new and more effective treatments is really important for patients with these life-threatening conditions.
This is a 'Phase III' study, which means it's a large and important step in developing new medicines. If olorofim proves to be safe and works well in this study, it could eventually become a new treatment choice for doctors and patients dealing with Aspergillus infections. The study is carefully designed to provide clear answers about the new medicine.
Key takeaways
- This study compares a new medicine (olorofim) with a standard one (AmBisome) for serious fungal infections.
- It aims to find out which treatment is safer and more effective for infections caused by Aspergillus mould.
- Participation involves receiving one of the treatments and regular health checks.
- The study is for adults aged 18 and over.
- Your health will be closely monitored throughout your involvement.
- You can stop participating at any time.
Who may be eligible?
To join 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 condition will be checked by the study doctors to make sure the treatment is suitable and safe for you. This often includes things like your medical history, any other medicines you are taking, and how severe your fungal infection is. You would need to have a confirmed invasive fungal infection caused by Aspergillus.
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 at least 18 years old?
- Do you have an invasive fungal infection caused by Aspergillus?
- Are you able to attend regular hospital or clinic visits?
- Are you willing to potentially receive either the new or standard treatment?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine, olorofim, or the standard medicine, AmBisome. You would be assigned to one of these groups by chance, like flipping a coin. You wouldn't be able to choose which treatment you receive, and your doctors also wouldn't know which one you are getting, to keep the study fair.
Taking part would involve regular visits to the hospital or clinic. During these visits, the study team would monitor your health very closely. This would include physical examinations, blood tests, and possibly scans to see how the infection is responding to the treatment. They would also ask you about any side effects you might be experiencing. You would also fill out questionnaires about your quality of life at certain times.
After you finish the main treatment period, there will be follow-up assessments to check on your long-term health. The total duration of your participation would involve the treatment period and then a period of follow-up visits.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What is an 'invasive fungal infection'?
It's a serious infection caused by a fungus or mould, like Aspergillus, that can spread to different parts of your body. It's especially dangerous for people with weakened immune systems.
What is Aspergillus?
Aspergillus is a common type of mould found almost everywhere, both indoors and outdoors. Most people breathe in Aspergillus spores every day without getting sick, but in some cases, it can cause severe infections.
What does 'randomised study' mean?
It means you'd be put into a treatment group (either olorofim or AmBisome) by chance. This helps make the study fair and ensures the results are reliable.
What is a 'Phase III' trial?
It's one of the final stages of testing a new medicine. It involves a larger group of patients and aims to confirm the medicine's effectiveness and safety before it can be considered for wider use.
Will I know which medicine I'm getting?
No, this is a 'blinded' study, meaning neither you nor your doctors will usually know if you're receiving olorofim or AmBisome. This helps keep study results unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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