Immune Regulation in Chronic Aspergillus Infection After... | NCT06135597

Studies
Immune Regulation in Chronic Aspergillus Infection After COVID-19 Infection

NCT06135597

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Aspergillosis

Interventions

This is a blood test without regarding to intervention nor diagnostic tests

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 12, 2023

First Submission Date that Met QC Criteria

Nov 12, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2023

Last Update Posted Date

Nov 18, 2023Actual

Name	Class
National Science and Technology Council	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to collect clinical cases and follow-up data from patients with chronic pulmonary aspergillosis, post-COVID-19 aspergillosis, and post-COVID-19 patients without aspergillosis. Using in vitro assays, we will measure the phagocytic function of neutrophils when stimulated by fungal hyphae, their ability to produce neutrophil extracellular traps (NETs), the expression of cell surface molecules at the time of enrollment, changes in cell surface molecule expression after stimulation with fungal hyphae, and the quantification of autoantibodies in the blood. This research will focus on the short-term (within 3 months), medium-term (6-12 months), and long-term (more than 12 months) changes in cell surface molecules and functions following infection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Aspergillosis	Patients with aspergillosis	Other: This is a blood test without regarding to intervention nor diagnostic tests
COVID	Patients with history of COVID infection and without aspergillosis	Other: This is a blood test without regarding to intervention nor diagnostic tests
Control	Patients without history of COVID infection and without aspergillosis	Other: This is a blood test without regarding to intervention nor diagnostic tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
This is a blood test without regarding to intervention nor diagnostic tests	Other	This is a blood test without regarding to intervention nor diagnostic tests	Aspergillosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	The study will observed for at least one year for overall survival	6 months intervel

Secondary Outcomes

Measure	Description	Time Frame
Oppertunistic infection	Infection not by aspergillus or COVID	yearly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed cases include patients diagnosed with pulmonary aspergillosis, acute or subacute Aspergillus infections, and aspergillosis in other anatomical sites (such as sinuses, middle ear, liver). Additionally, this study will enroll patients with chronic obstructive pulmonary disease (COPD), asthma, or those undergoing treatment for pulmonary tuberculosis who continue to exhibit worsening pulmonary radiological findings without a clear etiology, necessitating hospitalization or outpatient care for unexplained community-acquired pneumonia. Patients with bronchiectasis, emphysema, pulmonary fibrosis, or other chronic pulmonary conditions who are under continuous follow-up and treatment at our institution will also be included if clinically diagnosed with aspergillosis.

The control group will consist of patients who, based on clinical evidence, have no history of prior exposure to Aspergillus or aspergillosis infection after contracting COVID-19.

Exclusion Criteria:

Individuals aged below 20, pregnant women, patients with advanced-stage (stage II and above) lung cancer, individuals diagnosed with malignancies, patients with mental health disorders requiring consent from a legal guardian for participation, and those in critical end-stage conditions.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study enrolled patients with and without COVID infection, and with aspergillus coinfection.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
SF Huang	Contact	+886-28712121	7494	sfhuang.dr@gmail.com

Name	Affiliation	Role
SF Huang	Taipei Veterans General Hospital, Taipei, Taiwan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Shiang Fen Huang	Recruiting	Taipei		112	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections