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RecruitingPHASE3INTERVENTIONAL

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

This research study is looking into a new medicine called Fosmanogepix. It's designed to treat candidemia and invasive candidiasis, which are serious and potentially life-threatening fungal infections caused by a type of yeast called Candida. We want to find out if Fosmanogepix is a safe and effective treatment. Participants will either receive the new medicine or a standard, approved treatment. Both types of treatment are given first directly into a vein, and later, if suitable, as tablets or capsules. The study will compare how well Fosmanogepix works compared to the usual treatments. We're looking for adults aged 18 and over who have been diagnosed with one of these fungal infections.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Basilea Pharmaceutica
Enrolment target
450
Start
11 Dec 2024
Estimated completion
30 Jan 2028

What is this study about?

This study is looking into a serious fungal infection that can affect people, especially when they are already unwell. This infection is called candidemia or invasive candidiasis, and it's caused by a common type of yeast called Candida. These infections can be very serious, so doctors are always looking for better ways to treat them. This study is testing a new medicine, which we're calling Fosmanogepix, to see if it can help.

We want to find out if Fosmanogepix is safe and if it works as well as, or even better than, the treatments doctors usually give for these infections. By comparing the new medicine to existing ones, we can learn more about its potential to help patients in the future. We're hoping to show that Fosmanogepix is at least as good as the currently available treatments.

Taking part in a study like this helps us gather important information that can lead to new and improved ways of treating serious conditions. Your involvement could make a real difference in understanding how to fight these infections more effectively.

Key takeaways

  • Tests a new medicine, Fosmanogepix, for serious fungal infections.
  • Compares Fosmanogepix to standard treatments to check safety and effectiveness.
  • Treatment first given into a vein, then possibly as tablets/capsules.
  • Study lasts up to 6 weeks, with a follow-up visit.
  • Helps doctors find better ways to treat these infections.
  • Participation is voluntary; you can withdraw anytime.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and have been diagnosed with candidemia or invasive candidiasis within the last four days. It's important that your doctors can manage the source of your infection, for example, by removing any infected tubes or lines. Before joining, you or a legal guardian must also understand and agree to the study procedures.

However, there are reasons why you might not be able to take part. For instance, if your infection is caused by a specific type of Candida (Candida krusei) or certain deep-seated infections. You also wouldn't be able to join if your doctors think you have less than three days to live, or if you need kidney dialysis or similar treatments. Certain ongoing brain conditions, some HIV infections, or other serious health problems that might make taking part risky would also mean you can't join.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with candidemia or invasive candidiasis in the last 4 days?
  3. Can your doctors manage the source of your infection (e.g., remove infected lines)?
  4. Do you *not* have an infection caused by Candida krusei?
  5. Do you *not* need kidney dialysis currently?
  6. Do you *not* have a serious brain condition that is unrelated to your current infection?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new study medicine, Fosmanogepix, or one of the standard treatments for the infection. This will be decided by chance, like flipping a coin. Two out of three people will receive Fosmanogepix, and one out of three will receive a standard treatment (Caspofungin followed by Fluconazole).

Initially, both the study medicine and the standard treatments are given directly into a vein in your arm every day. This will usually happen at the hospital or clinic. If you get better and are well enough to go home, you might then switch to taking the medicine as tablets or capsules by mouth each day. You'll take these either at home or at the clinic, depending on your health.

The treatment will continue for up to six weeks, or until your infection has cleared up and your other symptoms have improved. Throughout this time, you'll have regular visits and checks to see how you're doing and if the treatment is working. After you finish the treatment, there will be one follow-up visit about six weeks later to check on your recovery. The total number of visits and the exact length of your participation will depend on how long your infection takes to clear.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment that isn't widely available yet, which might help your infection. However, like all medicines, Fosmanogepix might have side effects, and some people may experience mild, moderate, or even serious reactions to it. The standard treatments also have known potential risks and side effects. The study team will carefully monitor you for any problems. You are free to ask questions at any time and can leave the study at any point without it affecting your usual medical care.

Locations (142)

  • University of Alabama at Birmingham School of Medicine, Department of Medicine
    Verified postcode
    Birmingham, United States· Recruiting
  • City of Hope
    Verified postcode
    Duarte, United States· Recruiting
  • David Geffen School of Medicine at UCLA
    Verified postcode
    Los Angeles, United States· Recruiting
  • UC Davis Medical Center
    Verified postcode
    Sacramento, United States· Recruiting
  • Emory University Hospital - Clifton Road
    Verified postcode
    Atlanta, United States· Recruiting
  • Augusta University Medical Center
    Verified postcode
    Augusta, United States· Recruiting
  • Indiana University Methodist Hospital
    Verified postcode
    Indianapolis, United States· Recruiting
  • University of Kentucky College of Medicine
    Verified postcode
    Lexington, United States· Recruiting
  • Johns Hopkins Hospital
    Verified postcode
    Baltimore, United States· Recruiting
  • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center
    Verified postcode
    Ann Arbor, United States· Recruiting
  • DMC Harper University Hospital
    Verified postcode
    Detroit, United States· Recruiting
  • Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases
    Verified postcode
    Detroit, United States· Recruiting

Common questions

What is candidemia and invasive candidiasis?

These are serious fungal infections caused by a type of yeast called Candida, which can get into your bloodstream or other parts of your body.

What is Fosmanogepix?

Fosmanogepix is a new medicine being tested to see if it can safely and effectively treat these serious fungal infections.

Will I get the new medicine or a standard treatment?

You will be randomly assigned to receive either Fosmanogepix or a standard, approved treatment. It's like a lottery – two out of three people will get Fosmanogepix.

How long will I be on treatment?

Treatment can last up to six weeks, or until your infection has cleared and you're feeling better. There will also be a follow-up visit after treatment ends.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Manuel Häckl, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Phase 3 Efficacy and Safety Study of Fosmanogepix for the …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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