2025-523501-15-00招募中2 期
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.
Pauls Stradins Clinical University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年3月2日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.
研究概览
简要总结
To evaluate the efficacy of intrabronchial instillation of liposomal Amphotericin B for the treatment of simple pulmonary aspergilloma.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •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)
研究组 & 干预措施
AmBisome liposomāls amfotericīns B 50 mg pulveris infūziju šķīduma pagatavošanai
Test
干预措施: AmBisome liposomāls amfotericīns B 50 mg pulveris infūziju šķīduma pagatavošanai (Drug)
结局指标
主要结局
Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.
Relative change in lesion (aspergilloma) size, expressed as a percentage from baseline to post-treatment.
次要结局
- The proportion of patients in each treatment response category based on changes in aspergilloma (mycetoma) size from baseline to Week 8 visit, categorized as complete response (complete absorption of the lesion, 100% reduction in size), partial response (≥ 50% reduction in lesion size) and insufficient response (< 50% reduction or no change in lesion size).
- Proportion of patients with adverse events categorized by severity as mild, moderate or severe during treatment with intrabronchial instillation of liposomal Amphotericin B.
- The proportion of patients with change shift on the COPD Assessment Test (CAT) score from baseline to post-treatment assessment visit.
- The proportion of patients with disease progression during study treatment, defined as an increase in the size of aspergilloma (mycetoma) or progression to other forms of chronic pulmonary aspergillosis – chronic cavitary or fibrosing pulmonary aspergillosis, invasive pulmonary aspergillosis.
- Proportion of patients with hemoptysis during study treatment, categorized by severity as mild, moderate and severe.
研究者
Paula Gavare
Scientific
Pauls Stradins Clinical University Hospital
研究点 (1)
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