Clinical trial NCT06379568: Risk of Aspergillus Infection in Patients With Chronic Lung Disease
Official title: Risk of Aspergillus Infection in Patients With Chronic Structural Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection Lungs
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Descriptive statistical index
timeFrame: Information was collected on the day of admission
measure: Independent risk factor for aspergillus pneumonia
timeFrame: Statistical analysis was carried out after data collection within one month
measure: The area under ROC curve of risk factors for aspergillus pneumonia
timeFrame: Statistical analysis was carried out after data collection within two month
Secondary outcomes:
measure: Threshold analysis of aspergillus pneumonia
timeFrame: Statistical analysis was carried out after data collection within two month
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Lin Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: