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Anidulafungin

Clinical trials investigating Anidulafungin are studying how it is used in serious fungal infections, especially candidemia and invasive candidiasis, and also as part of treatment plans for other severe infections. These studies look at safety, effectiveness, and treatment length in adult patients with different infection types.

Table of contents

Clinical trials overview

All of the trials listed for Anidulafungin are Phase 3 studies, which means they are testing treatments in larger groups of patients to learn more about benefit and safety in real-world use.[1][2][3][4]

These are interventional studies, so researchers are assigning treatment plans and comparing results between groups.[1][2][3][4]

The studies focus on adults with serious fungal infections, especially candidemia, invasive candidiasis, and invasive mold infections.[1][3][4]

Trials in candidemia and invasive candidiasis

One completed Phase 3 trial studied adults with invasive candidiasis/candidemia and compared two treatment paths: an intravenous echinocandin followed by oral ibrexafungerp versus an intravenous echinocandin followed by oral fluconazole or best available therapy.[3]

Anidulafungin was one of the intravenous echinocandin options used in this study.[3]

The main outcome was all-cause mortality at Day 30, and the study also measured successful global response at the end of treatment in the EU population.[3]

A second Phase 3 trial, called CANDISHORT, studied adults with uncomplicated candidemia and compared a shorter treatment course with a longer one after the first negative blood culture.[4]

In this trial, Anidulafungin was one of several antifungal medicines used in the treatment options being tested.[4]

The main endpoint was all-cause mortality at Day 28 after the first negative blood test, with a small time window of plus or minus 2 days.[4]

Trial in invasive mold infections

One authorised Phase 3 study is testing fosmanogepix in adults with invasive mold infections caused by Aspergillus species, Fusarium species, Lomentospora prolificans, Mucorales fungi, or other multidrug resistant molds.[1]

Anidulafungin appears in the list of antifungal treatments used in the study treatment options, showing that it is part of the broader comparison set.[1]

The trial plans to enroll 210 participants and measures Day 42 all-cause mortality as the primary outcome.[1]

This study is important because it focuses on infections that are difficult to treat and may have limited treatment choices.[1]

Trial in severe infections and antibiotic use

The MODIFY trial is a Phase 3 study in adults with severe infections.[2]

Its goal is not mainly to test Anidulafungin alone, but to see whether a strategy using procalcitonin guidance and molecular-guided diagnosis can reduce the number of days patients receive empirical broad-spectrum antibiotics.[2]

Anidulafungin is included among the treatment options in this trial’s intervention list.[2]

The primary outcome is the number of days under treatment with broad-spectrum antibiotics in the MODIFY group compared with standard care.[2]

The trial plans to enroll 190 participants.[2]

Main outcomes being measured

The trials use outcomes that help show whether treatment is working and whether patients survive the infection.[1][2][3][4]

  • All-cause mortality: this means death from any cause during the study period, and it is used in several of the trials.[1][3][4]

  • Successful global response: this is a combined measure of how well the infection responds to treatment by the end of treatment.[3]

  • Days on broad-spectrum antibiotics: this measures how long patients need wide-coverage antibiotics, which is the key outcome in the MODIFY trial.[2]

  • Time after the first negative blood culture: this is used in the CANDISHORT study to compare shorter and longer treatment durations.[4]

What patients should know about these studies

These studies are designed for adults with serious fungal infections, and one study also includes adults with severe infections more broadly.[1][2][3][4]

Some trials compare Anidulafungin with other antifungal medicines, while others use it as part of a treatment strategy being tested against standard care.[1][2][3][4]

The studies are trying to answer practical questions such as which treatment works best, how long treatment should last, and whether patients can do well with fewer days of broad-spectrum antibiotics.[2][3][4]

Because these are Phase 3 studies, they are meant to give stronger evidence about treatment results in larger patient groups.[1][2][3][4]

Trial IDPhaseCondition studiedStatusEnrollment
2024-516216-16-00Phase 3Invasive mold infectionsAuthorised210
2022-502962-26-00Phase 3Severe infectionsAuthorised190
NCT05178862Phase 3Invasive Candidiasis/CandidemiaCompleted240
NCT06859671Phase 3Uncomplicated candidemiaAuthorised399

FAQ

  • What conditions are being studied in trials that include Anidulafungin? The trials listed study uncomplicated candidemia, invasive candidiasis/candidemia, and some invasive mold infections. One trial also includes Anidulafungin in a study of severe infections where the goal is to reduce unnecessary broad-spectrum antibiotic use.
  • Who can take part in these Anidulafungin trials? The target groups are mainly adults with serious fungal infections. Some studies focus on people with uncomplicated candidemia, while others include adults with invasive candidiasis or invasive mold infections.
  • What phase are the Anidulafungin trials? All of the trials listed are Phase 3 studies. Phase 3 means the treatment is being tested in larger groups of patients to better assess how well it works and how safe it is.
  • What are the main goals of these trials? The trials aim to measure outcomes such as all-cause mortality, successful global response, and the number of days patients need broad-spectrum antibiotics. One study also looks at whether a shorter treatment course is as effective as a longer one.
  • How is Anidulafungin being used in these studies? Anidulafungin is used as one of the study treatments in several infection trials. In these studies, it is compared with other antifungal medicines or used as part of a treatment strategy being tested.

Ongoing Clinical Trials on Anidulafungin

  • Study of fosmanogepix compared to standard antifungal drugs for treating invasive mold infections in adults

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium France Germany Greece Italy +2

  • Study comparing 7-day versus 14-day antifungal treatment for patients with uncomplicated candidemia using fluconazole, anidulafungin, or other medications

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    France

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

    Not recruiting

    3 1 1
    Investigated drugs:
    Belgium Bulgaria France Germany Greece Italy +1

  • Study on Avibactam and Drug Combination for Treating Severe Infections in Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece

Glossary

  • Candidemia: A bloodstream infection caused by Candida, a type of fungus.
  • Invasive candidiasis: A serious fungal infection that can spread beyond the blood into other parts of the body.
  • Uncomplicated candidemia: A blood Candida infection without the extra problems or spread that make treatment more complex.
  • Invasive mold infection: A serious infection caused by mold fungi that invade body tissues.
  • Phase 3: A late stage of clinical research that tests a treatment in larger groups of patients.
  • Interventional study: A trial where researchers assign a treatment or strategy to see what happens.
  • Enrollment: The number of people planned to join or already included in a trial.
  • All-cause mortality: Death from any cause during the study period.
  • Successful global response: A combined measure used by researchers to judge whether treatment is working well overall.
  • Broad-spectrum antibiotics: Antibiotics that act against many different bacteria. They are often used at first when the exact infection is not yet known.
  • Non-inferior: A study result showing that one treatment is not worse than another by more than a set amount.
  • Negative blood culture: A lab test showing no growth of the fungus or bacteria in the blood sample.

References