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Weekly rezafungin infusions for adults with chronic pulmonary aspergillosis and limited treatment options

A Phase 2, Multicentre, Open-label, Single Arm Study to Evaluate the Effectiveness and Safety of Rezafungin (as Acetate) in the Treatment of Chronic Pulmonary Aspergillosis (CPA) in Patients With Limited Treatment Options

Phase 2 Interventional Mundipharma Research Limited · NCT06794554

This will test whether weekly rezafungin infusions for six months can improve symptoms and lung findings in adults with chronic pulmonary aspergillosis who have few treatment options.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorMundipharma Research Limited Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations37 sites (Linz and 36 other locations)
Trial IDNCT06794554 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study gives adults with confirmed CPA weekly intravenous rezafungin for six months with monthly clinic visits for safety and efficacy checks. Key outcomes include patient-reported health via the St George's Respiratory Questionnaire, changes in weight, and radiological response on CT imaging. Eligible participants are adults with CPA of at least three months' duration who have limited options due to azole resistance, intolerance, or prior treatment failure. Safety monitoring includes regular clinical assessments and laboratory testing to detect adverse events.

Who should consider this trial

Good fit: Adults aged 18 or older with a confirmed CPA diagnosis (per ESCMID/ERS criteria for ≥3 months) who have limited treatment options because of azole resistance, intolerance, or inadequate response are the intended participants.

Not a fit: Patients who can be effectively managed with standard oral azole therapy, those with active tuberculosis or non-tuberculous mycobacterial pulmonary infection, or those with contraindications to IV antifungal treatment are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, rezafungin could provide a once-weekly IV antifungal option that improves symptoms and lung disease for people with azole-resistant or azole-intolerant CPA.

How similar studies have performed: Echinocandins have demonstrated activity against Aspergillus in other contexts, but clinical evidence for long-acting rezafungin in CPA is limited, so this use is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Males or females ≥18 years of age
3. Established diagnosis of CPA according to ESCMID/ERS criteria (2016) which includes all the following, which should be present for ≥3 months:

   * one or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, night sweats, fever and dyspnoea)
   * slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax
   * immunological, microbiological or molecular evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index \>0.5 or BALF galactomannan index \>1), positive Aspergillus IgG, or positive PCR
   * exclusion of active tuberculosis or non-tuberculous mycobacterial pulmonary infection or disorders that will prevent evaluation of outcome over 6 months. Patients on anti-mycobacterial therapy can be enrolled if their mycobacterial infection is stabilised
4. 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
5. Antifungal treatment is indicated according to the opinion of the investigator due to radiological changes consistent with CPA progression OR high burden of symptoms
6. 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.

   * Definitions: Woman of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
   * A postmenopausal state: no menses for 12 months without an alternative medical cause.
   * Abstinence: refraining from heterosexual intercourse (only if it corresponds to the subject's usual lifestyle)
7. Willingness to comply with all aspects and assessments required in this study

Exclusion Criteria:

1. Subjects with invasive aspergillosis, aspergillus nodules, or simple aspergilloma
2. Known or suspected hypersensitivity to rezafungin for Injection or any of its excipients
3. 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
4. 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
5. Administration of any other echinocandin or intravenous antifungal treatment within 3 months of screening
6. Administration of ≥15mg prednisolone daily (or other equivalent immunosuppressant) for at least 3 weeks within 4 weeks of screening
7. Acute respiratory infections considered inadequately treated in the opinion of the Principal Investigator. Any subjects diagnosed with an acute respiratory infection during the screening period should be re-screened following the required course of appropriate treatment and enrolled when considered adequately treated.
8. Subjects with active malignancy who are receiving chemotherapy or radiation therapy
9. Severely immunocompromising conditions according to the opinion of the investigator such as bone marrow transplantation, neutropenia, or have received cancer chemotherapy within last 6 months
10. Subjects on the palliative care pathway
11. Any other condition or laboratory abnormality that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study
12. A. Meets National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher B. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease)
13. Planned or ongoing therapy at Screening with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher.
14. Pregnant or lactating females

Where this trial is running

Linz and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Pulmonary AspergillosisChronic pulmonary aspergillosisRezafunginRezzayo
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.