Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Fungal Status and Prognosis in ABPA (ABPAFUNGAL)

7 juli 2026 bijgewerkt door: Qian Qi, Qianfoshan Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

114

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Qian Qi, Dr.
Telefoonnummer: +86 13706380314
E-mail: qiqianqlh@163.com

Studie Locaties

China
- Shandong
  - Jinan, Shandong, China, 250014
    - Werving
    - Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
    - Contact:
      
      Qian Qi, Dr.
      
      Telefoonnummer: +86 13706380314
      
      E-mail: qiqianqlh@163.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.
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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Annual acute exacerbation rate Tijdsspanne: 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).	12 months after enrollment
Time to first acute exacerbation Tijdsspanne: 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.	12 months after enrollment

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Immunological response indicators Tijdsspanne: 12 months after enrollment	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.	12 months after enrollment
Pulmonary function parameters Tijdsspanne: 12 months after enrollment	Changes in pulmonary function including FEV1 (% predicted)	12 months after enrollment
Radiological changes Tijdsspanne: 12 months after enrollment	Changes in chest CT features including extent of bronchiectasis, mucus plugging, and high-attenuation mucus (HAM) scores.	12 months after enrollment
Treatment response Tijdsspanne: 12 months after enrollment	Treatment response including corticosteroid dosage and duration, antifungal therapy regimen and duration, symptom improvement, and changes in IgE levels and radiological lesion absorption.	12 months after enrollment
Clinical outcomes and healthcare utilization Tijdsspanne: 12 months after enrollment	Number of acute exacerbations, hospitalization frequency, hospital length of stay, and other adverse clinical outcomes during follow-up.	12 months after enrollment
Changes in FEV1/FVC ratio Tijdsspanne: 12 months after enrollment	Changes in FEV1/FVC ratio	12 months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Qianfoshan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2025

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

1 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 juli 2026

Eerst geplaatst (Werkelijk)

8 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)