Risk of Aspergillus Infection in Patients With Chronic Structural Lung Disease
Conditions: Fungal Infection Lungs
Sponsor: Lin Chen

Official Title: Risk of Aspergillus infection in patients with
chronic structural lung disease
Short Title: Risk of Aspergillus infection in patients with chronic lung
disease
NCT Number: Pending
Study Duration: July 1, 2022 - January 31, 2024
Funding Source: Sichuan Provincial People's Hospital
Principal Investigator: Dr. Lin Chen
Affiliation: Sichuan Provincial People's Hospital
Address: 32# W. Sec 2, 1st Ring Rd., Chengdu, Sichuan, China

Contact Information:
Email: chenlinhx@med.uestc.edu.cn
Phone: +86 18111585286
Document Date: January 31, 2024
Study Protocol
Title: Risk of Aspergillus infection in patients with chronic structural lung disease
Objective: Identify the risk factors associated with fungal infections and investigate acute exacerbation
in these patients.
Background: More attention has been paid to improving the quality of life and long-term management
of patients with structural lung diseases such as chronic obstructive pulmonary disease (COPD) and
bronchiectasis, whose repeated acute exacerbations lead to greater dependence on systemic and inhaled
glucocorticoids. At the same time, the incidence of aspergillus pneumonia also increased.
Methodology:

Study Design: The risk factors of aspergillus pneumonia were compared between aspergillus
colonization group and aspergillus pneumonia group.

Participants:Patients with chronic lung disease were identified as positive for Aspergillus
fumigatus through sputum microscopy. According to diagnostic criteria, patients diagnosed
with IPA and CPA and were assigned to the Aspergillosis pneumonia group, while the
remaining patients were included in the Aspergillus colonization group. Then,Risk factors for
aspergillus pneumonia, invasive pulmonary aspergillus disease, and chronic pulmonary
aspergillus disease, such as the use of high-dose corticosteroids, inhaled corticosteroids, and
the extent of damage to basic lung structures, were identified by comparing the aspergillus
colonization group with the aspergillus infection group.

Procedures:


Patients diagnosed with chronic lung disease were screened out who were qualified
by sputum microscopy and positive for aspergillus in sputum culture.

The chest high-resolution computed tomography (HRCT), serum Aspergillus specific
IgG antibody, serum aspergillus IgM antibody and serum GM test were performed.

The risk factors of aspergillus infection group and aspergillus colonization group
were compared.

Ethics Approval: Granted by the Medical Ethics Committee of Sichuan Provincial People's
Hospital.
Statistical Analysis Plan
Data Analysis Strategy:
1.
Descriptive Statistics:

Summarize participant characteristics using means and standard deviations for
continuous variables and frequencies for categorical variables.
2.
Identify independent risk factors:

Independent risk factors for aspergillus infection were determined by multivariate
logistic regression analysis.
3.
Comparison Between Groups:

The area under ROC curve (AUC) was used to evaluate the classification effect of
the binary classification model among Aspergillus pneumonia group, IPA group and
CPA group.
4.
Threshold Analysis:

Specific cut-off values for Aspergillus specific IgG antibody × lung structural injury
image score was determined to maximize diagnostic accuracy, focusing on sensitivity,
specificity, and Youden index.
Software: Statistical analysis will be conducted using SPSS version 25.0 or a similar statistical
package.
Ethical Considerations: Data will be anonymized to protect patient confidentiality, with all
procedures carried out in accordance with the Declaration of Helsinki.