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Ibrexafungerp

Clinical trials are investigating Ibrexafungerp in people with invasive candidiasis and candidemia, which are serious fungal infections in the blood or body. These studies look at whether treatment is safe and effective after initial intravenous therapy, and compare it with other standard oral treatments.

Table of Contents

Trial overview

The source data includes one clinical trial of Ibrexafungerp, NCT05178862, which studied people with invasive candidiasis and candidemia.[1]

This was an interventional study, which means the researchers gave study treatments and then measured the results.[1]

The trial asked whether treatment with an intravenous echinocandin followed by oral Ibrexafungerp could work as well as intravenous echinocandin followed by oral fluconazole.[1]

Who the trial is for

The study focused on people with serious Candida infections, specifically invasive candidiasis or candidemia.[1]

Candidemia means Candida infection in the blood, and invasive candidiasis means the infection has spread inside the body.[1]

The source data does not give more detailed age or other entry rules, so only the listed condition can be confirmed here.[1]

Treatments being compared

The trial compared two treatment paths after the first intravenous antifungal medicine.[1]

One path used an intravenous echinocandin first, then oral Ibrexafungerp.[1]

The other path used an intravenous echinocandin first, then oral fluconazole, or best available therapy in some settings.[1]

The source data also lists several study drugs and placebos used in the trial design, including placebo for Ibrexafungerp and placebo for fluconazole.[1]

Study phase and design

NCT05178862 was a Phase 3 trial.[1]

Phase 3 studies usually test a treatment in a larger group of people and compare it with standard care or another active treatment.[1]

The planned enrollment was 240 participants.[1]

The brief summary says the goal was to show that the Ibrexafungerp treatment path was non-inferior to the fluconazole path.[1]

Main outcomes being measured

The main outcome was all-cause mortality at Day 30 in the ITT population.[1]

All-cause mortality means death from any cause during the study period, and ITT population means the analysis includes the patients assigned to treatment.[1]

The trial also measured the percentage of people with successful global response at the end of treatment.[1]

This second outcome was noted as being for EU only in the source data.[1]

What the completed status means

The study status is listed as Completed, which means the trial has finished collecting its planned data.[1]

Because the trial is completed, the source data describes the study plan and outcomes, but not the final results.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05178862 Phase 3 Invasive Candidiasis / Candidemia Completed 240

FAQ

  • What is being studied in Ibrexafungerp trials? The main study is testing Ibrexafungerp after an intravenous echinocandin for invasive candidiasis and candidemia. It compares this approach with oral fluconazole after the same first treatment.
  • Who may take part in these trials? The trial is for people with invasive candidiasis or candidemia. These are patients with serious Candida infections, often treated first with an intravenous antifungal medicine.
  • What phase is the Ibrexafungerp study? The study is a Phase 3 trial. Phase 3 means it is testing the treatment in a larger group of people to compare results with standard care.
  • What are the main results being measured? The trial measures all-cause mortality at Day 30, which means death from any cause within 30 days. It also measures successful global response at the end of treatment.
  • Is this trial still ongoing? No. The trial listed in the source data is completed. That means the study has finished collecting its main data.

Ongoing Clinical Trials on Ibrexafungerp

  • Study Comparing Ibrexafungerp and Fluconazole for Treating Candidemia or Invasive Candidiasis in Patients

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria France Germany Greece Italy +1

Glossary

  • Invasive candidiasis: A serious infection caused by Candida yeast that spreads inside the body, not just on the skin or in the mouth.
  • Candidemia: Candida infection in the blood. This is a medical emergency and needs prompt treatment.
  • Intravenous (IV): Given through a vein, usually by a line in the arm or another vein.
  • Oral use: Taken by mouth, usually as a tablet or capsule.
  • Echinocandin: A group of antifungal medicines used as the first treatment in the trial before the oral medicine.
  • Fluconazole: An oral antifungal medicine used as the comparison treatment in the study.
  • Non-inferior: A study result showing that one treatment is not worse than the comparison treatment by more than a small, set amount.
  • All-cause mortality: Death from any cause, whether related to the infection or not.
  • ITT population: Intention-to-treat population, meaning all patients who were assigned to treatment are included in the analysis.
  • End of treatment (EOT): The point when the planned treatment period ends and results are checked.
  • Successful global response: A combined study result used to judge whether the infection improved in the way the trial planned.

References