Fungal Status and Prognosis in ABPA (ABPAFUNGAL)
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
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Qian Qi, Dr.
- Número de teléfono: +86 13706380314
- Correo electrónico: qiqianqlh@163.com
Ubicaciones de estudio
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Shandong
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Jinan, Shandong, Porcelana, 250014
- Reclutamiento
- Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
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Contacto:
- Qian Qi, Dr.
- Número de teléfono: +86 13706380314
- Correo electrónico: qiqianqlh@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Fungal-Positive ABPA
Patients diagnosed with allergic bronchopulmonary aspergillosis according to ISHAM 2024 criteria who demonstrate at least one positive result in sputum or bronchoalveolar lavage fluid (BALF) fungal testing, including fungal culture, galactomannan (GM) assay, or targeted next-generation sequencing (tNGS) detecting Aspergillus species.
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Fungal-Negative ABPA
Patients diagnosed with allergic bronchopulmonary aspergillosis according to ISHAM 2024 criteria with negative results in all fungal tests performed on sputum or bronchoalveolar lavage fluid (BALF), including fungal culture, galactomannan (GM) assay, and targeted next-generation sequencing (tNGS).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Annual acute exacerbation rate
Periodo de tiempo: 12 months after enrollment
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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).
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12 months after enrollment
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Time to first acute exacerbation
Periodo de tiempo: 12 months after enrollment
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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.
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12 months after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Immunological response indicators
Periodo de tiempo: 12 months after enrollment
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Changes in immunological biomarkers including total serum IgE, Aspergillus-specific IgE and IgG levels, peripheral blood eosinophil counts, and fractional exhaled nitric oxide (FeNO) will be evaluated during follow-up.
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12 months after enrollment
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Pulmonary function parameters
Periodo de tiempo: 12 months after enrollment
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Changes in pulmonary function including FEV1 (% predicted)
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12 months after enrollment
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Radiological changes
Periodo de tiempo: 12 months after enrollment
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Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores.
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12 months after enrollment
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Treatment response
Periodo de tiempo: 12 months after enrollment
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Treatment response including corticosteroid dosage and duration, antifungal therapy regimen and duration, symptom improvement, and changes in IgE levels and radiological lesion absorption.
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12 months after enrollment
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Clinical outcomes and healthcare utilization
Periodo de tiempo: 12 months after enrollment
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Number of acute exacerbations, hospitalization frequency, hospital length of stay, and other adverse clinical outcomes during follow-up.
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12 months after enrollment
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Changes in FEV1/FVC ratio
Periodo de tiempo: 12 months after enrollment
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Changes in FEV1/FVC ratio
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12 months after enrollment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones fúngicas invasivas
- Enfermedades del sistema inmunológico
- Infecciones del Tracto Respiratorio
- Infecciones
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Infecciones bacterianas y micosis
- Enfermedades Pulmonares Fúngicas
- Micosis
- Aspergilosis pulmonar
- Aspergilosis
- Aspergilosis pulmonar invasiva
- Bronquiectasias
- Aspergilosis Broncopulmonar Alérgica
Otros números de identificación del estudio
- ABPA-005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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