Fungal status and prognosis in ABPA: looking at who improves based on fungal tests

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational cohort classifies ABPA patients by fungal microbiology status using culture, GM testing, and mNGS on sputum or BALF. It compares baseline features, labs, imaging, treatment responses, and long-term outcomes such as exacerbation rate and time to first exacerbation between fungal-positive and fungal-negative groups. Participants are followed for up to 12 months with serial assessments. The study uses ISHAM 2024 criteria for ABPA diagnosis and includes adults hospitalized with available mycological data. No intervention is specified beyond observational data collection across centers in Jinan, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qian Qi, Dr.
• Email: qiqianqlh@163.com
• Phone: +86 13706380314

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-based ABPA recurrence predictor in adults with ABPA

  A machine-learning model is being tested to see if it can predict the chance of an ABPA flare within a year in adults with ABPA during a stable phase.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07714863

• Biologic treatment for adults with ABPA and severe asthma

  This project will test whether biologic medicines help adults with ABPA who have severe asthma and elevated eosinophils.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362693

• Bronchoscopic airway clearance with amphotericin B spraying for ABPA

  This study will try bronchoscopic airway clearance plus amphotericin B spraying to see if it helps adults with allergic bronchopulmonary aspergillosis (ABPA) who have mucus plugs.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07362667

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

• Can a multi-omics and AI model predict ABPA relapse within 1 year in adults?

  This study tests a machine learning model that uses multi-omics and clinical data to predict the 1-year relapse risk for adults with ABPA who are in a stable state.

  Recruiting Qianfoshan Hospital · Jinan, Shandong · NCT07611838

• Immune status and disease control in airway inflammatory diseases

  This project will test whether specific blood immune cell patterns relate to disease control in adults with asthma, COPD, bronchiectasis, or obstructive sleep apnea by comparing them with healthy volunteers.

  Recruiting First Affiliated Hospital of Ningbo University · Ningbo, Zhejiang · NCT07493629

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.