Itraconazole Therapy In Bronchiectasis With Airway Mold: A Single-Arm Pilot Trial Of Feasibility, Safety, And Impact On Respiratory Symptoms And Airway Microbiome Diversity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of eligible patients who consent and enroll
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold. Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention. The study will also explore the impact on respiratory symptoms and airway microbiome diversity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years seen at Mycobacterial and Bronchiectasis Clinic (MMBC) in Rochester
- •Diagnosis of bronchiectasis confirmed by MMBC provider and chest CT
- •Within the last 3 months - culture growth of a mold in high quantity ('many') or culture growth of at least two distinct mold species in any quantity
- •Not actively on antimicrobial therapy AND no current plan to initiate antimicrobial therapy at the time of enrollment, as determined by treating provider
- •Ability to produce spontaneous sputum at Visit 1.
排除标准
- •Known diagnosis of allergic bronchopulmonary aspergillosis or invasive fungal disease
- •Use of the following medications: rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, dofetilide, quinidine, dronedarone, simvastatin, lovastatin, certain immunosuppressants (tacrolimus, cyclosporine, sirolimus, everolimus) and anticoagulants (rivaroxaban, apixaban, edoxaban, warfarin).
- •Abnormal baseline liver function tests (ALT, AST, alkaline phosphatase, or bilirubin > upper limit of normal)
- •Prolonged QTc interval on baseline ECG (>460 ms in females or >450 ms in males)
- •History of congestive heart failure (black box warning), known cardiomyopathy, or arrhythmias
- •Pregnancy or lactation
- •Known hypersensitivity or contraindication to azole antifungal therapy
- •Prior use of systemic antifungals within the past 3 months
研究组 & 干预措施
Bronchiectasis
Subjects with bronchiectasis and airway mold
干预措施: Itraconazole 200 mg (Drug)
结局指标
主要结局
Proportion of eligible patients who consent and enroll
时间窗: 2 years
Recruitment will be measured as the proportion of eligible patients who consent and enroll out of patients screened, reported as a percentage, with a benchmark of \>60%.
Number of patients to achieve successful medication adherence
时间窗: 2 years
Adherence will be assessed through pill counts with successful adherence defined as ≥ 70% of doses taken and achieving a therapeutic trough level.
Proportion of participants who complete treatment without adverse effects
时间窗: 2 years
Tolerability will be evaluated as the proportion of participants who complete the 6-week course without discontinuation due to adverse effects, with a target benchmark of ≥ 70%.
Proportion of patients retained for complete study
时间窗: 2 years
Retention will be defined as the proportion of participants completing all scheduled study visits (baseline, day 7 and end of treatment), with a goal of ≥ 80% retention.
次要结局
- Number of participants meeting hepatic safety discontinuation criteria(Baseline, 1 week)
- Number of participants with a QTc interval greater than 500 ms(Baseline, 1 week)