Risk of Aspergillus Infection in Patients With Chronic Lung Disease

NCT ID: NCT06379568

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Fungal Infection Lungs

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aspergillus pneumonia group

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

No intervention

Intervention Type OTHER

No intervention

control group

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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lin Chen

OTHER

Sponsor Role lead

Responsible Party

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Lin Chen

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lin Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Locations

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Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40654578 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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SichuanPPHLC01

Identifier Type: -

Identifier Source: org_study_id

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