Fungal Infection LungsNCT06379568
Risk of Aspergillus Infection in Patients With Chronic Lung Disease
An observational study of Fungal Infection Lungs, run by Lin Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection Lungs
- How many people
- 209 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fungal Infection Lungs
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Aspergillus pneumonia group | According to diagnostic criteria , patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group Receives: Other: No intervention | |
| control group | The remaining patients without IPA and CPA were included in the Aspergillus colonization group Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistical index
Summarize participant characteristics using means and standard deviations for continuous variables and frequencies for categorical variables
Measured: 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.
Measured: 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
Measured: Statistical analysis was carried out after data collection within two month
Secondary outcomes (1)
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.
Measured: Statistical analysis was carried out after data collection within two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jul 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fungal Infection LungsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Chen, Sichuan Provincial People's Hospital
- Investigators
- Lin Chen, doctor, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379568
- Sponsor's protocol ID
- SichuanPPHLC01
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40654578
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Aspergillus Infection in Patients With Chronic Structural Lung Disease
- ClinicalTrials.gov ID
- NCT06379568
- Acronym / sponsor ID
- SichuanPPHLC01
- Conditions
- Fungal Infection Lungs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Lin ChenUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspergillus pneumonia group | – | Other: No interventionAccording to diagnostic criteria , patients diagnosed with IPA and CPA and were assigned to the Aspergillosis pneumonia group |
| control group | – | Other: No interventionThe remaining patients without IPA and CPA were included in the Aspergillus colonization group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Aspergillus pneumonia group, control group |
Primary outcome
Descriptive statistical index
Time frame: Information was collected on the day of admission
Summarize participant characteristics using means and standard deviations for continuous variables and frequencies for categorical variables
Independent risk factor for aspergillus pneumonia
Time frame: Statistical analysis was carried out after data collection within one month
Independent risk factors for aspergillus infection were determined by multivariate logistic regression analysis.
The area under ROC curve of risk factors for aspergillus pneumonia
Time frame: Statistical analysis was carried out after data collection within two month
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
1 secondary outcome
Threshold analysis of aspergillus pneumonia
Time frame: Statistical analysis was carried out after data collection within two month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 40654578Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Chen, doctor principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection Lungs, run by Lin Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistical index (time frame: Information was collected on the day of admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.