BridgeMD
Rezafungin for treatment of chronic pulmonary aspergillosis (CPA) in adults with limited treatment options
EU CTIS ID: 2024-519575-26-00
What this study is testing
To evaluate the effectiveness of 6 months’ rezafungin in the treatment of CPA in subjects with limited treatment options according to clinical and radiological response as measured by the St George's Respiratory Questionnaire (SGRQ), weight, and computed tomography (CT) imaging
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females ≥18 years of age (≥19 years in Republic of Korea), willing and able to provide written informed consent.
- Patients with an established diagnosis of CPA according to ESCMID/ERS/ECMM criteria (2016) which must be present for ≥3 months, unable to receive systemic azole antifungal therapy, and where 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 must agree to use one highly effective contraceptive methods of birth control, or sexual abstinence, 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, unless the partner is >2 years post-menopausal or otherwise sterile, and agree not to donate sperm while participating in the study and for 120 days from the last dose of study drug.
- [A full list of inclusion criteria is included in the study protocol.]
You likely can't join if
- Subjects with invasive aspergillosis or simple aspergilloma, known or suspected hypersensitivity to rezafungin, any echinocandin or any of their excipients, and current participation in another interventional treatment trial with an investigational agent.
- Recent use of an investigational medicinal product (IMP) within 28 days or 5 half-lives of the IMP, whichever is greater, administration of any other echinocandin or IV antifungal treatment within 3 months of screening, administration of ≥15mg prednisolone daily (or equivalent corticosteroid) for at least 3 weeks within 4 weeks of screening, OR a peripheral neutrophil count <0.5x10[to the power of 9]/L.
- Acute respiratory infections considered inadequately treated, subjects with active malignancy who are undergoing chemotherapy or radiation therapy.
- Other conditions or laboratory abnormality that, in the opinion of the Investigator, would put the subject at unacceptable risk or interfere with the assessments included in the study.
- Subjects with NCI-CTCAE Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy and/or a history of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder, therapy 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 NCI-CTCAE Grade 1 or higher.
- Pregnant or lactating females.
See the full eligibility criteria
Who can join
- Males or females ≥18 years of age (≥19 years in Republic of Korea), willing and able to provide written informed consent.
- Patients with an established diagnosis of CPA according to ESCMID/ERS/ECMM criteria (2016) which must be present for ≥3 months, unable to receive systemic azole antifungal therapy, and where 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 must agree to use one highly effective contraceptive methods of birth control, or sexual abstinence, 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, unless the partner is >2 years post-menopausal or otherwise sterile, and agree not to donate sperm while participating in the study and for 120 days from the last dose of study drug.
- [A full list of inclusion criteria is included in the study protocol.]
What rules you out
- Subjects with invasive aspergillosis or simple aspergilloma, known or suspected hypersensitivity to rezafungin, any echinocandin or any of their excipients, and current participation in another interventional treatment trial with an investigational agent.
- Recent use of an investigational medicinal product (IMP) within 28 days or 5 half-lives of the IMP, whichever is greater, administration of any other echinocandin or IV antifungal treatment within 3 months of screening, administration of ≥15mg prednisolone daily (or equivalent corticosteroid) for at least 3 weeks within 4 weeks of screening, OR a peripheral neutrophil count <0.5x10[to the power of 9]/L.
- Acute respiratory infections considered inadequately treated, subjects with active malignancy who are undergoing chemotherapy or radiation therapy.
- Other conditions or laboratory abnormality that, in the opinion of the Investigator, would put the subject at unacceptable risk or interfere with the assessments included in the study.
- Subjects with NCI-CTCAE Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy and/or a history of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder, therapy 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 NCI-CTCAE Grade 1 or higher.
- Pregnant or lactating females.
- [A full list of exclusion criteria is included in the study protocol.]
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.