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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Qian Qi, Dr.
- Telefonnummer: +86 13706380314
- E-Mail: qiqianqlh@163.com
Studienorte
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Shandong
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Jinan, Shandong, China, 250014
- Rekrutierung
- 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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Kontakt:
- Qian Qi, Dr.
- Telefonnummer: +86 13706380314
- E-Mail: qiqianqlh@163.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Annual acute exacerbation rate
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Immunological response indicators
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Invasive Pilzinfektionen
- Erkrankungen des Immunsystems
- Infektionen der Atemwege
- Infektionen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Bronchialerkrankungen
- Überempfindlichkeit der Atemwege
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Bakterielle Infektionen und Mykosen
- Lungenerkrankungen, Pilz
- Mykosen
- Pulmonale Aspergillose
- Aspergillose
- Invasive pulmonale Aspergillose
- Bronchiektasen
- Aspergillose, Allergische Bronchopulmonale
Andere Studien-ID-Nummern
- ABPA-005
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