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Voriconazole

Clinical trials investigating Voriconazole are studying how it performs in different fungal infections, including candidemia and invasive mold infection. These studies look at safety, survival, and treatment success in adults with confirmed or suspected infection, and in some cases people with chronic pulmonary aspergillosis.

Table of Contents

Overview of the Voriconazole trials

The trial data show studies of Voriconazole in several serious fungal infections, including candidemia, invasive candidiasis, invasive mold infections, suspected invasive mould infection, and chronic pulmonary aspergillosis.[1][2][3][4][5]

Most of the listed studies are Phase 3 trials, and one study is a Phase 2 trial.[1][2][3][4][5]

Conditions studied

One study looks at chronic pulmonary aspergillosis, a long-lasting lung infection caused by Aspergillus, and it excludes people with single aspergilloma.[1]

Two studies focus on candidemia and invasive candidiasis, which are serious Candida infections that can involve the bloodstream and other body sites.[2][4]

Two studies focus on invasive mold infections or suspected invasive mould infection, which are serious infections caused by molds and may be treated quickly because they can become severe.[3][5]

Study design, phases, and who can join

These are all interventional studies, which means the researchers give one or more treatments and compare the results.[1][2][3][4][5]

The chronic pulmonary aspergillosis study is a prospective, randomized, single-blind study in non- or mildly-immunocompromised patients, meaning the researchers follow people forward in time, assign treatment by chance, and keep one side of the study unaware of the assignment.[1]

The candidemia and invasive candidiasis studies include adults with uncomplicated disease or invasive disease, while the mold infection studies include adults with confirmed or suspected invasive mold infection.[2][3][4][5]

Enrollment ranges from 80 people in the Phase 2 study to 399 people in one Phase 3 study.[2][5]

Main outcomes being measured

The chronic pulmonary aspergillosis study measures therapeutic efficacy at 6 months, using both clinical improvement or stability and radiological improvement.[1]

The candidemia study measures all-cause mortality at Day 28 after the first negative blood test, and it tests whether a shorter treatment course is not worse than a longer one by too much.[2]

The invasive mold infection study measures all-cause mortality at Day 42.[3]

The invasive candidiasis/candidemia study measures all-cause mortality at Day 30 and also checks for successful global response at end of treatment in the EU only.[4]

The Phase 2 suspected invasive mould infection study measures all-cause mortality at Day 42 and also records serious adverse events and other treatment-emergent adverse events, including kidney, electrolyte, liver, infusion-related, photophobia, and photosensitivity events.[5]

Trial-by-trial summary

NCT03656081 compares a six-month treatment plan in chronic pulmonary aspergillosis and looks at whether adding nebulised Ambisome® to itraconazole improves clinical and radiological results compared with itraconazole alone.[1]

NCT06859671 studies short-duration therapy for uncomplicated candidemia and measures survival at Day 28 after the first negative blood culture.[2]

2024-516216-16-00 studies adults with invasive mold infections caused by several mold types, including Aspergillus, Fusarium, Lomentospora prolificans, and Mucorales fungi, and measures Day 42 mortality.[3]

NCT05178862 compares two treatment regimens for invasive candidiasis/candidemia and measures Day 30 mortality and global response at end of treatment.[4]

2025-522835-32-00 is a Phase 2 study of early antifungal therapy for suspected invasive mould infection and measures survival and safety outcomes.[5]

Trial ID Phase Condition studied Status Enrollment
NCT03656081 Phase 3 Chronic pulmonary aspergillosis Authorised 224
NCT06859671 Phase 3 Uncomplicated candidemia Authorised 399
2024-516216-16-00 Phase 3 Invasive mold infections Authorised 210
NCT05178862 Phase 3 Invasive candidiasis / candidemia Completed 240
2025-522835-32-00 Phase 2 Suspected invasive mould infection Authorised 80

FAQ

  • What kinds of conditions are studied in Voriconazole trials? The trials in this data study infections such as uncomplicated candidemia, invasive candidiasis, invasive mold infections, suspected invasive mold infection, and chronic pulmonary aspergillosis.
  • Who can take part in these trials? Participants are usually adults with a specific fungal infection. Some studies focus on non- or mildly-immunocompromised patients, while others include adults with suspected or confirmed invasive infection.
  • What phases are the Voriconazole trials in? The listed trials are mainly Phase 3, with one Phase 2 study. Phase 3 trials usually test whether a treatment works well and is safe in larger groups.
  • What outcomes are measured in these studies? Common outcomes include all-cause mortality, treatment response, and clinical or radiological improvement. Some studies also measure serious side effects and other treatment-emergent adverse events.
  • Is Voriconazole always studied alone? No. In these trials, Voriconazole is often compared with other antifungal treatments or used as part of a treatment plan. The goal is to see how it performs against other options.

Ongoing Clinical Trials on Voriconazole

  • A study to compare the effectiveness of EL219 against liposomal amphotericin B and voriconazole for patients with suspected invasive mould infections.

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Italy Spain

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

    Recruiting

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

  • Study Comparing Itraconazole and Nebulised Amphotericin B with Itraconazole Alone for Patients with Chronic Pulmonary Aspergillosis

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

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

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

  • 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

  • Candidemia: A bloodstream infection caused by Candida, a type of fungus.
  • Invasive candidiasis: A serious Candida infection that can spread beyond the bloodstream to organs or tissues.
  • Invasive mold infection: A fungal infection caused by molds that can spread into body tissues and may be severe.
  • Suspected infection: An infection that doctors think may be present, even before all test results are confirmed.
  • Phase 2: A trial phase that looks at early signs of benefit and safety in a smaller group of people.
  • Phase 3: A larger trial phase that compares treatments and checks how well they work and how safe they are.
  • All-cause mortality: Death from any cause during the study period.
  • Primary outcome: The main result a trial is designed to measure.
  • Intent-to-treat population: All participants who were assigned to a study group, even if they did not finish treatment exactly as planned.
  • Radiological improvement: Better findings on imaging tests, such as scans or X-rays.
  • Serious adverse event: A harmful medical event that is severe, life-threatening, or needs hospital care.

References