Fungal Status and Prognosis in ABPA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQianfoshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1.Coexisting pulmonary fungal infections (e.g., invasive pulmonary aspergillosis) or other confirmed non-fungal pulmonary infections.

Trial population

This study will include adult patients (≥18 years old) diagnosed with allergic bronchopulmonary aspergillosis (ABPA) according to the 2024 ISHAM diagnostic criteria. The study population consists of retrospectively identified cases from participating hospitals' electronic medical records and prospectively enrolled patients during the study period. Eligible patients must have undergone sputum or bronchoalveolar lavage fluid (BALF) sampling with at least one mycological test (culture, GM assay, mNGS, or tNGS) and have complete clinical, imaging, laboratory, treatment, and follow-up data. Participants will be stratified into BALF/sputum mycological positive and negative groups. Patients with coexisting pulmonary fungal infections, missing key data, or inability to complete follow-up will be excluded.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

114 Participants
are grouped into 2 trial groups
Group A: Fungal-Positive ABPA
Group B: Fungal-Negative ABPA

Trial outcomes

Primary outcomes

1

Annual acute exacerbation rate

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 frame
12 months after enrollment
2

Time to first acute exacerbation

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.

Time frame
12 months after enrollment

Secondary outcomes

1

Immunological response indicators

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.

Time frame
12 months after enrollment
2

Pulmonary function parameters

Changes in pulmonary function including FEV1 (% predicted)

Time frame
12 months after enrollment
3

Radiological changes

Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores.

Time frame
12 months after enrollment
4

Treatment response

Treatment response including corticosteroid dosage and duration, antifungal therapy regimen and duration, symptom improvement, and changes in IgE levels and radiological lesion absorption.

Time frame
12 months after enrollment

Other outcomes

Sponsors and contacts

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