이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Fungal Status and Prognosis in ABPA (ABPAFUNGAL)

2026년 7월 7일 업데이트: 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.

연구 개요

상태

모병

정황

연구 유형

관찰

등록 (추정된)

114

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Qian Qi, Dr.
전화번호: +86 13706380314
이메일: qiqianqlh@163.com

연구 장소

중국
- Shandong
  - Jinan, Shandong, 중국, 250014
    - 모병
    - Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
    - 연락하다:
      
      Qian Qi, Dr.
      
      전화번호: +86 13706380314
      
      이메일: qiqianqlh@163.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Annual acute exacerbation rate 기간: 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 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Immunological response indicators 기간: 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 기간: 12 months after enrollment	Changes in pulmonary function including FEV1 (% predicted)	12 months after enrollment
Radiological changes 기간: 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 기간: 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 기간: 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 기간: 12 months after enrollment	Changes in FEV1/FVC ratio	12 months after enrollment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Qianfoshan Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 1일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 1일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)