Clinical Characteristics and Prognostic Outcomes of Allergic Bronchopulmonary Aspergillosis Patients Stratified by Fungal Microbiological Status in Sputum or Bronchoalveolar Lavage Fluid: A Multicenter Bidirectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Annual acute exacerbation rate
研究概览
简要总结
This multicenter bidirectional cohort study aims to investigate the clinical characteristics and prognostic outcomes of patients with allergic bronchopulmonary aspergillosis (ABPA) stratified by fungal microbiological status in sputum or bronchoalveolar lavage fluid (BALF).
Patients diagnosed with ABPA according to the ISHAM 2024 criteria will be classified into fungal-positive and fungal-negative groups based on results from fungal culture, galactomannan (GM) testing, and metagenomic next-generation sequencing (mNGS) of sputum or BALF samples.
The study will compare baseline clinical features, laboratory findings, radiological characteristics, treatment response, and long-term outcomes, including acute exacerbation rate and time to first exacerbation, between the two groups.
All participants will be followed for up to 12 months with serial clinical and laboratory assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •1.Adult patients (≥18 years old) diagnosed with allergic bronchopulmonary aspergillosis (ABPA) according to the 2024 International Society for Human and Animal Mycology (ISHAM) diagnostic criteria.
- •2.Patients hospitalized during the study period in participating centers with sputum or bronchoalveolar lavage fluid (BALF) collection performed.
- •3.At least one mycological test performed on sputum or BALF, including fungal culture, galactomannan (GM) assay, metagenomic next-generation sequencing (mNGS), or targeted next-generation sequencing (tNGS), with clearly interpretable results (positive or negative).
- •4.Availability of complete and traceable clinical data, including medical history, imaging, laboratory tests, treatment records, and follow-up information, with no critical missing data.
- •5.Willingness to participate in follow-up and signed informed consent (for prospective participants), with good compliance for follow-up.
- •6.No systemic antifungal therapy or other interventions that may significantly affect mycological test results within 1 month prior to enrollment.
排除标准
- •1.Coexisting pulmonary fungal infections (e.g., invasive pulmonary aspergillosis) or other confirmed non-fungal pulmonary infections.
- •2.Presence of other structural lung diseases, such as pulmonary tuberculosis, lung cancer, or lung abscess.
- •3.Severe immunodeficiency or other significant allergic pulmonary diseases that may confound the diagnosis of ABPA.
- •4.Absence of sputum or BALF samples, or lack of valid mycological test results. 5.Incomplete key clinical data (e.g., total IgE, Aspergillus-specific IgE/IgG, imaging, or pulmonary function data) or inability to complete at least 3 months of follow-up.
- •6.Systemic antifungal treatment within 1 month prior to enrollment or participation in another interventional clinical trial.
- •7.Contraindications to bronchoscopy/BAL procedures or known severe allergy to relevant reagents used in testing.
结局指标
主要结局
Annual acute exacerbation rate
时间窗: 12 months after enrollment
The annual acute exacerbation rate will be defined as the number of disease exacerbations requiring systemic corticosteroids, antibiotics, or hospitalization within 12 months of follow-up in patients with allergic bronchopulmonary aspergillosis (ABPA), stratified by fungal microbiological status in sputum or bronchoalveolar lavage fluid (BALF).
Time to first acute exacerbation
时间窗: 12 months after enrollment
Time from enrollment to the first occurrence of acute exacerbation of ABPA, defined by clinical worsening requiring systemic corticosteroid escalation, hospitalization, or documented physician diagnosis.
次要结局
- Immunological response indicators(12 months after enrollment)
- Pulmonary function parameters(12 months after enrollment)
- Radiological changes(12 months after enrollment)
- Treatment response(12 months after enrollment)
- Clinical outcomes and healthcare utilization(12 months after enrollment)
- Changes in FEV1/FVC ratio(12 months after enrollment)
研究者
Qian Qi
Prof.
Qianfoshan Hospital