Immunity and Nasal Fungal Colonization

January 30, 2022 updated by: Taichung Veterans General Hospital

Host Immunity and Nasal Fungal Colonization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichang, Taiwan, 40705
        • Department of Otolaryngology, Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy volunteers
immunocompromised subjects
Other: nasal irrigation
regular saline nasal rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
nasal lavage pooled fungal microbiota
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
nasal lavage aspergillus qPCR
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

July 20, 2020

Study Completion (Actual)

July 27, 2020

Study Registration Dates

First Submitted

January 30, 2022

First Submitted That Met QC Criteria

January 30, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 30, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE18237B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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