Risk of Aspergillus Infection in Patients With Chronic Lung Disease

NCT06379568 | Completed

• 1 other identifier: SichuanPPHLC01
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fungal Infection Lungs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Threshold analysis of aspergillus pneumonia

  Statistical analysis was carried out after data collection within two month

Study Arms (2)

Aspergillus pneumonia group

According to diagnostic criteria , patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group

Other: No intervention

control group

The remaining patients without IPA and CPA were included in the Aspergillus colonization group

Other: No intervention

Interventions

No intervention OTHER

No intervention

Aspergillus pneumonia group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lin Chen: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Related Publications (1)

• Zhang R, Yang L, Fang H, Xie Q, Tang H, Chen L. Non-invasive monitoring of Aspergillus infections in chronic lung disease patients: a combined serology and HRCT imaging approach. Front Cell Infect Microbiol. 2025 Jun 27;15:1494522. doi: 10.3389/fcimb.2025.1494522. eCollection 2025.

  PMID: 40654578 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect patient's blood to detect aspergillus specific IgG antibody, IgM antibody and so on

Study Officials

• Lin Chen, doctor

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 23, 2024
• Study Start: July 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (1)