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Effectiveness and Safety of Rezafungin in Adults with Chronic Pulmonary Aspergillosis Who Have Limited Treatment Options

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study evaluates the effectiveness and safety of rezafungin for treating chronic pulmonary aspergillosis (CPA), a long-term fungal infection that affects the lungs. The research focuses on adult patients who have limited treatment options, particularly those who cannot receive the standard azole antifungal therapy. Rezafungin is being studied as an alternative medication for patients whose condition is progressing or who have significant symptoms from this fungal lung infection.

The purpose is to determine if six months of rezafungin treatment can improve the condition of patients with CPA who have few treatment alternatives. During the study, patients will receive rezafungin and be monitored for changes in their respiratory symptoms, weight, and lung condition through computed tomography (CT) imaging, which uses X-rays to create detailed pictures of the lungs. Patients will also complete questionnaires about their breathing symptoms and quality of life.

The study will track how participants respond to the medication by measuring changes in their Aspergillus antibody levels (indicators of the fungal infection), need for additional medications, hospitalizations, and any side effects that may occur during treatment. This is a phase 2 study, which means it aims to gather preliminary data on whether the medication works for this specific condition and what side effects might occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting the Study

    After joining the study, you will begin a 6-month treatment with rezafungin acetate (REZZAYO). This medication is designed to treat chronic pulmonary aspergillosis (CPA), which is a fungal infection in the lungs caused by Aspergillus that has been present for 3 months or longer.

    The medication will be administered as a solution for infusion. This means you will receive it through an intravenous (IV) line. The dosage is 200 mg of rezafungin acetate in the form of a powder that will be made into a concentrated solution.

  2. Step 2

    Baseline Assessment

    At the beginning of the study, you will complete several assessments to establish your starting condition. These include:

    - Completing the St George's Respiratory Questionnaire, which asks about your breathing problems and how they affect your life

    - Having your weight measured

    - Undergoing a CT scan of your chest (a detailed X-ray that shows images of your lungs)

    - Having blood tests to measure Aspergillus IgG levels (antibodies that your body produces in response to the fungal infection)

    - Completing quality of life questionnaires including the EQ-5D-5L and Respiratory Symptom score

  3. Step 3

    3-Month Assessment

    After 3 months of treatment, you will return for a follow-up assessment that includes:

    - Repeating the St George's Respiratory Questionnaire

    - Having your weight measured again to check for any changes

    - Blood tests to measure Aspergillus IgG levels

    - Completing the EQ-5D-5L and Respiratory Symptom questionnaires

    - Physical examination and laboratory tests to monitor your overall health and check for any side effects

    - Assessment of any changes in antibiotic or steroid prescriptions you may need

    - Checking respiratory samples to see if Aspergillus is still present

  4. Step 4

    6-Month Final Assessment

    At the end of the 6-month treatment period, you will complete a final assessment that includes all the same tests as the 3-month assessment plus:

    - A final CT scan of your chest to assess any changes in your lungs

    - Complete evaluation of your response to treatment based on improvements in symptoms, weight changes, and lung imaging

    - Final review of any hospitalizations that may have occurred during the study

    - Final safety assessment including review of any side effects experienced during the study

  5. Step 5

    Safety Monitoring Throughout Study

    Throughout the entire 6-month study period, your safety will be monitored through:

    - Tracking of any adverse events (side effects or unexpected health issues)

    - Monitoring for any serious adverse events that might require medical attention

    - Regular check-ins regarding your health status

    - Testing to see if the Aspergillus fungus has developed resistance to the medication

    - Recording any hospitalizations related to your lung condition

Who can join the trial?

7 criteria

  • You must be at least 18 years old and willing to provide written consent to participate.
  • You must have chronic pulmonary aspergillosis (CPA) diagnosed according to established medical criteria that has been present for at least 3 months.
  • You must be unable to receive standard azole antifungal therapy for your condition.
  • Your doctor must determine that you need antifungal treatment because of either:
    • Changes seen on your lung scans that show your CPA is getting worse, or
    • You have severe symptoms from your CPA
    • If you are a woman who can become pregnant, you must agree to use two highly effective birth control methods or practice sexual abstinence during the study and for 30 days after your last dose of the study medication.
    • If you are a man, you must either be vasectomized, abstain from heterosexual intercourse, or agree to use barrier contraception during the study and for 120 days after your last dose of the study medication. You also must agree not to donate sperm during this time.

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions to medications similar to rezafungin
  • Pregnant or breastfeeding women
  • People who have certain liver problems
  • Those with severe kidney disease
  • Individuals with active cancer that is not in remission (remission means the cancer is under control or gone)
  • People who have had an organ transplant
  • Those with HIV infection or AIDS
  • Individuals with certain heart conditions
  • Those taking medications that might interact badly with the study drug
  • People who are participating in other clinical trials
  • Individuals who have a condition that might interfere with the study procedures or results
  • Those who cannot follow the study schedule or requirements
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Investigated drugs

Rezafungin (as acetate) is an antifungal medication being studied for the treatment of chronic pulmonary aspergillosis (CPA), which is a fungal infection affecting the lungs. It works by disrupting the formation of the fungal cell wall, helping to stop the growth of the fungus. This medication is administered through an infusion and is being evaluated for patients who have limited treatment options for their condition.

What is already known about the treatment

Rezafungin – An antifungal medication administered as an intravenous infusion, currently being investigated for the treatment of chronic pulmonary aspergillosis (CPA) in patients with limited treatment options. Rezafungin belongs to the echinocandin class of antifungals that works by inhibiting the synthesis of beta-(1,3)-D-glucan, an essential component of fungal cell walls, thereby preventing fungal growth and reproduction. The medication is still in clinical trials (Phase 2) and is not yet approved for general use, but shows promise for patients with chronic fungal infections who haven't responded well to conventional antifungal treatments.

Investigated diseases

Chronic pulmonary aspergillosis (CPA) is a progressive respiratory infection caused by Aspergillus fungi, typically Aspergillus fumigatus. It affects the lungs and develops slowly over months or years, often in people with pre-existing lung conditions such as tuberculosis, COPD, or sarcoidosis. The fungus colonizes cavities or damaged areas in the lungs, forming fungal balls (aspergillomas) or causing progressive fibrosis and lung destruction. CPA typically manifests with symptoms including chronic cough, shortness of breath, fatigue, weight loss, and occasionally hemoptysis (coughing up blood). Over time, without intervention, the infection gradually destroys lung tissue, leading to declining respiratory function and worsening quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519575-26-00Protocol codeMR907-2502Estimated enrolment68 patientsSponsorMundipharma Research Limited

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