In short
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.
Key points
- Clinical trials investigating Voriconazole in this data focus on serious fungal infections, including candidemia, invasive candidiasis, invasive mold infections, suspected invasive mould infection, and chronic pulmonary aspergillosis. Most of the studies are Phase 3, with one Phase 2 study. The target groups are adults, and one study also focuses on non- or mildly-immunocompromised patients. The main outcomes include survival, treatment success, and clinical or radiological improvement. Some trials compare Voriconazole with other antifungal treatments or use it in a treatment strategy alongside other medicines. One study also tracks serious and treatment-emergent adverse events.
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.
Most of the listed studies are Phase 3 trials, and one study is a Phase 2 trial.
Conditions studied
One study looks at chronic pulmonary aspergillosis, a long-lasting lung infection caused by Aspergillus, and it excludes people with single aspergilloma.
Two studies focus on candidemia and invasive candidiasis, which are serious Candida infections that can involve the bloodstream and other body sites.
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.
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.
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.
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.
Enrollment ranges from 80 people in the Phase 2 study to 399 people in one Phase 3 study.
Main outcomes being measured
The chronic pulmonary aspergillosis study measures therapeutic efficacy at 6 months, using both clinical improvement or stability and radiological improvement.
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.
The invasive mold infection study measures all-cause mortality at Day 42.
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.
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.
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.
NCT06859671 studies short-duration therapy for uncomplicated candidemia and measures survival at Day 28 after the first negative blood culture.
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.
NCT05178862 compares two treatment regimens for invasive candidiasis/candidemia and measures Day 30 mortality and global response at end of treatment.
2025-522835-32-00 is a Phase 2 study of early antifungal therapy for suspected invasive mould infection and measures survival and safety outcomes.