Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Fungal Status and Prognosis in ABPA (ABPAFUNGAL)

7. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

114

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shandong
      • Jinan, Shandong, Kina, 250014
        • Rekruttering
        • Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annual acute exacerbation rate
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Immunological response indicators
Tidsramme: 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
Tidsramme: 12 months after enrollment
Changes in pulmonary function including FEV1 (% predicted)
12 months after enrollment
Radiological changes
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months after enrollment
Changes in FEV1/FVC ratio
12 months after enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qianfoshan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2025

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABPA-005

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Allergisk bronkopulmonal aspergillose

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uruguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner