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New hope for rare lung infection: weekly drug shows promise in early trial

NCT ID NCT06794554

Disease control Sponsor: Mundipharma Research Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called rezafungin for people with a long-term lung infection caused by a fungus (chronic pulmonary aspergillosis) who have few other treatment choices. About 60 adults will receive the drug once a week for 6 months. Researchers will check if the treatment improves symptoms and lung scans, and monitor for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aspergillosis pulmonary aspergilloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pulmonary aspergillosis

Contacts and locations

Locations

  • Asklepios Lungenfachklinik Gauting

    Gauting, Germany

  • Brussels University Hospital

    Brussels, Belgium

  • CHU Amiens Picardie

    Amiens, France

  • CHU Arnaud de Villeneuve

    Montpellier, France

  • CHU Bordeaux

    Pessac, France

  • CHU UCL Namur

    Yvoir, Belgium

  • Chonnam National University Hospital

    Gwangju, South Korea

  • Evangelische Lungenklinik Berlin

    Berlin, Germany

  • Hospital La Fe

    Valencia, Spain

  • Hospital Sant Joan de Deu de Martorell

    Martorell, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Humanitas Research Hospital

    Rozzano, Italy

  • INMI Lazzaro Spallanzaniconsu

    Roma, Italy

  • Imperial College Hospital

    London, United Kingdom

  • Institut Coeur Poumon CHU

    Lille, France

  • Kepler University Hospital

    Linz, Austria

  • Leeds Teaching Hospital

    Leeds, United Kingdom

  • Manchester University Hospital

    Manchester, United Kingdom

  • Országos Korányi Pulmonológiai Intézet

    Budapest, Hungary

  • Radboud Universitair Medisch Centrum Stichting

    Nijmegen, Netherlands

  • Ramón y Cajal Hospital

    Madrid, Spain

  • Royal Brompton Hospital, Guy's and St. Thomas' Hospital

    London, United Kingdom

  • Royal Papworth Hospital

    Cambridge, United Kingdom

  • Seoul National University Bundang Hospital

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • UZ Gent

    Ghent, Belgium

  • University College London (UCL) Hospitals

    London, United Kingdom

  • University Hospital Leuven

    Leuven, Belgium

  • University Hospitals of Derby and Burton

    Derby, United Kingdom

  • University of Cologne

    Cologne, Germany

  • University of Dundee

    Dundee, United Kingdom

  • University of Genova, San Martino Hospital

    Genova, Italy

  • University of Pisa

    Pisa, Italy

  • Vall d'Hebron Barcelona Hospital Campus

    Barcelona, Spain

  • Western General Hospital

    Edinburgh, United Kingdom

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