Immunity and Nasal Fungal Colonization | NCT05231499

Studies
Immunity and Nasal Fungal Colonization

NCT05231499

Sponsor

Taichung Veterans General Hospital

Status

Completed

Last Update Posted

Feb 9, 2022Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Colonization, Asymptomatic

Interventions

nasal irrigation

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2018Actual

Primary Completion Date

Jul 20, 2020Actual

Completion Date

Jul 27, 2020Actual

First Submitted Date

Jan 30, 2022

First Submission Date that Met QC Criteria

Jan 30, 2022

First Posted Date

Feb 9, 2022Actual

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

Jan 30, 2022

Last Update Posted Date

Feb 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Fungal colonization causes opportunistic infection that may manifest when the host's immune status deteriorates. The purpose of this study was to determine the prevalence of fungal colonization in immunocompromised subjects compared to healthy controls.

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

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy volunteers
immunocompromised subjects			Other: nasal irrigation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nasal irrigation	Other	regular saline nasal rinse	immunocompromised subjects

Measure	Description	Time Frame
nasal lavage pooled fungal microbiota		1 month

Measure	Description	Time Frame
nasal lavage aspergillus qPCR		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Immunocompromised subjects included those who had known risk factors for fungal infection, including malignant diseases, diabetes, autoimmune disorders, renal or hepatic insufficiency, organ transplantation, or use of immunosuppressants
Healthy volunteers had neither sinonasal symptoms nor nasal endoscopic inflammation.

Exclusion Criteria:

Patients were excluded if they were under 20 years old, were receiving antifungal medication, or were pregnant.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Immunocompromised subjects have rhinosinusitis or not using nasal irrigation or not using nasal irrigation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Otolaryngology, Taichung Veterans General Hospital		Taichang		40705	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

Condition Browse Module

MeSH Terms

ID	Term
D058345	Asymptomatic Infections

Ancestor Terms

ID	Term
D007239	Infections
D058070	Asymptomatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055556	Nasal Lavage

Ancestor Terms

ID	Term
D007507	Therapeutic Irrigation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided