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A Phase 2, monocentric, prospective, nonrandomized, open-label, experimental study to evaluate efficacy and safety of intrabronchial instillation of liposomal Amphotericin B in patients with simple pulmonary aspergilloma.
EU CTIS ID: 2025-523501-15-00
What this study is testing
To evaluate the efficacy of intrabronchial instillation of liposomal Amphotericin B for the treatment of simple pulmonary aspergilloma.
- 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
- Diagnosis of (simple) pulmonary aspergilloma. Diagnosis of (simple) pulmonary aspergilloma is made in concordance with 2016 ESCMID/ERS guidelines for diagnosis and management of chronic pulmonary aspergillosis (Single pulmonary cavity containing a fungal ball, with serological or microbiological evidence implicating Aspergillus spp. in a non-immunocompromised patient with minor or no symptoms). The diagnosis is made based on the typical findings on chest CT scan (a rounded mass within a pre-existing pulmonary cavity, air crescent sign around the mass), combined with one of the following tests: • Positive Aspergillus Ag (Galactomannan) in bronchoalveolar lavage fluid and/or serum • Aspergillus Spp. culture positive in BAL fluid • Aspergillus-IgG antibody positive • Other diagnoses excluded - mainly pulmonary TB (sputum or BAL microscopy and cultures negative for M. tuberculosis)
- Age 18 to 80 years
- Surgical resection of aspergilloma not possible or not indicated, or the patient has refused surgical treatment
- Systemic antifungal treatment not indicated or refused, or the patient has previously failed systemic antifungal treatment (currently not receiving)
You likely can't join if
- Not signed informed consent, refusal to participate in the study
- Coagulation abnormalities: • Severe thrombocytopenia < 30 x10 9/L • Elevated INR > 2.50
- Hypersensitivity to Amphotericin B class antifungal drugs
- Systemic antifungal therapy indicated, or the patient is currently receiving such therapy
- Surgical resection of pulmonary aspergilloma is indicated and is possible
- Severe hemoptysis, requiring bronchial artery embolisation or surgical treatment
See the full eligibility criteria
- Diagnosis of (simple) pulmonary aspergilloma. Diagnosis of (simple) pulmonary aspergilloma is made in concordance with 2016 ESCMID/ERS guidelines for diagnosis and management of chronic pulmonary aspergillosis (Single pulmonary cavity containing a fungal ball, with serological or microbiological evidence implicating Aspergillus spp. in a non-immunocompromised patient with minor or no symptoms). The diagnosis is made based on the typical findings on chest CT scan (a rounded mass within a pre-existing pulmonary cavity, air crescent sign around the mass), combined with one of the following tests: • Positive Aspergillus Ag (Galactomannan) in bronchoalveolar lavage fluid and/or serum • Aspergillus Spp. culture positive in BAL fluid • Aspergillus-IgG antibody positive • Other diagnoses excluded - mainly pulmonary TB (sputum or BAL microscopy and cultures negative for M. tuberculosis)
- Age 18 to 80 years
- Surgical resection of aspergilloma not possible or not indicated, or the patient has refused surgical treatment
- Systemic antifungal treatment not indicated or refused, or the patient has previously failed systemic antifungal treatment (currently not receiving)
- Not signed informed consent, refusal to participate in the study
- Coagulation abnormalities: • Severe thrombocytopenia < 30 x10 9/L • Elevated INR > 2.50
- Hypersensitivity to Amphotericin B class antifungal drugs
- Systemic antifungal therapy indicated, or the patient is currently receiving such therapy
- Surgical resection of pulmonary aspergilloma is indicated and is possible
- Severe hemoptysis, requiring bronchial artery embolisation or surgical treatment
- Pregnancy
- More than 1 mycetoma on chest CT scan
- Severe impairment in lung function, defined as FEV1 < 30 %
- Contraindications to performing elective bronchoscopy: • Hemodynamically unstable patients • Hypoxaemia (SpO2 < 88% on room air) • Previously known chronic type II respiratory failure (pCO2 > 45 mmHg on arterial blood gas analysis) • Recent myocardial infarction (< 3 months)
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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.