Active not recruitingPHASE3INTERVENTIONAL

Olorofim Aspergillus Infection Study

This study is looking at a new medicine called olorofim, which is designed to treat a serious fungal infection known as invasive aspergillosis (IA). IA can be very dangerous, particularly for people with weakened immune systems. Currently available medicines sometimes have limitations, such as side effects, drug interactions, or not working against certain resistant forms of the fungus. This study aims to find out if olorofim is as good as, or better than, an existing treatment called AmBisome®, followed by standard care. Researchers want to check olorofim's effectiveness, safety, and how well patients tolerate it. This is especially important for patients who haven't improved with other common anti-fungal treatments, called azoles.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

F2G Biotech GmbH

Enrolment target

225

Start

31 Mar 2022

Estimated completion

01 Nov 2026

Invasive Aspergillosis

What is this study about?

Invasive aspergillosis (IA) is a severe fungal infection that can be very serious, especially for people with weakened immune systems. Even with current treatments, the risk of serious complications or even death can be high. This is partly because some forms of the fungus (called *Aspergillus*) have become resistant to certain medicines, or these medicines can have side effects and interact with other medications.

This study is exploring a new medicine called olorofim. This medicine works in a different way to existing treatments and could be effective against fungi that have become resistant. It also has different potential side effects and can be taken as a tablet, which might be more convenient for patients. The study aims to compare olorofim with a widely used medication, AmBisome®, which is usually given through a drip, followed by the usual 'standard of care' treatments.

The main goal is to find out if olorofim is a safe and effective treatment for IA, particularly for patients whose infection hasn't improved with standard azole treatments or who can't take them. By participating, you could help doctors understand if olorofim is a good new option for fighting this challenging infection.

Key takeaways

A study comparing a new anti-fungal medicine (olorofim) with an existing one (AmBisome®) for invasive aspergillosis.
Aimed at patients whose infection hasn't responded to standard treatments.
Olorofim is an experimental drug with a different way of working.
Participation involves close health monitoring and regular hospital visits.
You can leave the study at any time.
The study aims to find more effective and safer ways to treat this serious infection.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and weigh more than 30 kg (about 4 stone 10 pounds). You must have a confirmed or highly suspected case of invasive aspergillosis (IA) that is affecting your lungs or other parts of your body. The infection should have been diagnosed recently, and you should not have been on specific anti-fungal treatment for longer than 28 days for this current infection. Importantly, your doctors must believe that AmBisome® is a suitable treatment option for you.

There are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have a known allergy to any of the study medications. The study also cannot include people with certain other types of fungal infections, specific heart conditions, or liver problems. If you have HIV but are not currently receiving treatment for it, you also would not be able to participate. This helps ensure the study is as safe as possible for everyone involved.

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 and weigh more than 30 kg?
Do you have a new or recently diagnosed invasive aspergillosis infection?
Are you able to take AmBisome® safely?
Are you not pregnant or breastfeeding?
Do you not have certain other serious medical conditions like severe liver problems or specific heart issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the new medicine, olorofim, or the existing treatment, AmBisome®, followed by the usual standard care for your condition. Your doctors will regularly monitor your health very closely throughout the study. This will involve scheduled visits to the clinic, where you might have blood tests, scans, and other medical checks to see how you are responding to the treatment and to monitor for any side effects. You will need to take the study medication as directed, and the study team will guide you on how to do this. The total duration of your participation in the study will depend on your individual treatment plan and follow-up, but the study team will explain all the details before you make a decision.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You would receive close medical monitoring and access to a new investigational treatment or an established effective therapy for your condition. This could lead to an improvement in your invasive aspergillosis. However, like all medicines, both olorofim and AmBisome® can have side effects, and some might be serious. The study team will explain all known side effects and monitor you carefully. There's no guarantee that the treatment will work for everyone, and it's important to remember that you can decide to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (140)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California Davis Health System
Verified postcode
Sacramento, United States
UCSF Helen Diller Medical Center at Parnassus Heights
Verified postcode
San Francisco, United States
University of Florida
Verified postcode
Gainesville, United States
Augusta University
Verified postcode
Augusta, United States
University of Chicago Medical Center
Verified postcode
Chicago, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
The Johns Hopkins Hospital
Verified postcode
Baltimore, United States
NIH Clinical Center ,NIAID,NIH
Verified postcode
Bethesda, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
University of Michigan
Verified postcode
Ann Arbor, United States

Common questions

What is invasive aspergillosis?

It's a serious fungal infection caused by a common mould called Aspergillus, which can affect people with weakened immune systems.

What is the new medicine, olorofim?

It's an experimental anti-fungal drug that works in a new way, being tested to see if it can treat invasive aspergillosis, especially in cases where other treatments haven't worked.

What is AmBisome®?

AmBisome® is an established and commonly used anti-fungal medicine given through a drip, which is effective against various serious fungal infections, including invasive aspergillosis.

Why is this study important?

This study aims to find better and safer treatment options for invasive aspergillosis, particularly for patients who don’t respond to or can’t take current main treatments.

Will I have to pay to be in the study?

No, all study-related medical care and medication will be provided at no cost to you.