Risk of Aspergillus Infection in Patients With Chronic Lung Disease

Risk of Aspergillus Infection in Patients With Chronic Structural Lung Disease

Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined.

Study Overview

• Status: Completed
• Conditions: Fungal Infection Lungs
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 209

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Non-repeat patients with chronic lung disease were included in the suspected pulmonary aspergillosis study group. According to the current study inclusion criteria, patients were excluded due to unqualified sputum specimens or negative culture results, together with patients lacked HRCT image data. Qualified patients were finally included. According to different group definitions, patients without IPA and CPA were classified into the Aspergillus colonization group and patients with IPA and CPA were included in the aspergillus infection group.

Description

Inclusion Criteria:

1. Age : at least 18 years old ;
2. Imageological examination : Patients who complete high-resolution computed tomography (HRCT) images of the chest;
3. Serological examination : Patients who complete serological test results, including serum aspergillus specific IgG antibody, serum aspergillus IgM antibody and GM antigen detection.

Exclusion Criteria:

1. immunodeficiency conditions : Patients diagnosed with HIV infection, hematological malignancies, and autoimmune diseases.
2. Critically ill patients : Those who require mechanical ventilation in the ICU and have established various types of cardiopulmonary bypass.
3. Inadequate Clinical Data: Inability to provide reliable diagnostic measurements or insufficient clinical information.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aspergillus pneumonia group; According to diagnostic criteria , patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group	Other: No intervention; No intervention
control group; The remaining patients without IPA and CPA were included in the Aspergillus colonization group	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive statistical index	Summarize participant characteristics using means and standard deviations for continuous variables and frequencies for categorical variables	Information was collected on the day of admission
Independent risk factor for aspergillus pneumonia	Independent risk factors for aspergillus infection were determined by multivariate logistic regression analysis.	Statistical analysis was carried out after data collection within one month
The area under ROC curve of risk factors for aspergillus pneumonia	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	Statistical analysis was carried out after data collection within two month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Threshold analysis of aspergillus pneumonia	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.	Statistical analysis was carried out after data collection within two month

Collaborators and Investigators

• Sponsor: Lin Chen
• Investigators: Principal Investigator: Lin Chen, doctor, Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Lung Diseases; Infections; Communicable Diseases; Mycoses; Aspergillosis
• Other Study ID Numbers: SichuanPPHLC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No