Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatmen… (NCT06794554) | Clinical Trial Compass
RecruitingPhase 2
Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options
Austria, Belgium60 participantsStarted 2025-06-30
Plain-language summary
The goal of this clinical trial is to to evaluate the drug rezafungin in the treatment of Chronic Pulmonary Aspergillosis (CPA) in male and female patients aged 18 years and over with limited treatment options.
The study aims to answer whether 6 months of rezafungin treatment is effective and safe in patients with chronic pulmonary aspergillosis with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire, weight, and CT imaging.
Participants will:
* Be given the drug rezafungin every week for 6 months.
* Visit the clinic once a month for checkups and tests.
* Complete questionnaires on thier health and wellbeing.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent
✓. Males or females ≥18 years of age
✓. Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months:
Exclusion criteria
✕. Unable to receive systemic azole antifungal therapy due to any of the following: documented or anticipated resistance, intolerance, contraindication (e.g. due to drug-drug interactions or organ dysfunction), inability to take oral medication, or lack of availability. NOTE: the administration of rezafungin is monotherapy only, and subjects currently on azoles who are able to remain on therapy are not eligible
✕. Antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms
✕. Female subjects of child-bearing potential \<2 years post-menopausal (unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence (only possible if it corresponds to the subject's usual lifestyle) while participating in this study, and for 30 days after the last dose of study drug. Male subjects must be vasectomized, abstain from heterosexual intercourse, or agree to use barrier contraception (condom with spermicide), and agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug, unless the partner is \>2 years post-menopausal or otherwise sterile.
What they're measuring
1
Change from baseline in clinical and radiological response at 6 months
✕. Willingness to comply with all aspects and assessments required in this study
✕. Subjects with invasive aspergillosis, aspergillus nodules, or simple aspergilloma
✕. Known or suspected hypersensitivity to rezafungin for Injection or any of its excipients
✕. Current participation in another interventional treatment trial with an investigational agent. Participation in another interventional treatment trial is permitted during the follow-up period of the study
✕. Recent use of an investigational medicinal product within 28 days or 5 half-lives of the investigational medicinal product, whichever is greater, to prevent overlapping toxicities when this study's investigational product is dosed, or presence of an investigational device at the time of screening. In some cases, use of investigational products may be acceptable in consultation with the Sponsor's Medical Monitor