NCT05231499

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

January 30, 2022

Last Update Submit

January 30, 2022

Conditions

Colonization, Asymptomatic

Keywords

colonizationmicrobiotafungiimmunocompromised

Outcome Measures

Primary Outcomes (1)

  • nasal lavage pooled fungal microbiota

    1 month

Secondary Outcomes (1)

  • nasal lavage aspergillus qPCR

    1 month

Study Arms (2)

healthy volunteers

immunocompromised subjects

Other: nasal irrigation

Interventions

nasal irrigationOTHER

regular saline nasal rinse

immunocompromised subjects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Taichung Veterans General Hospital

Taichang, 40705, Taiwan

Location

MeSH Terms

Conditions

Asymptomatic Infections

Interventions

Nasal Lavage

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2022

First Posted

February 9, 2022

Study Start

August 20, 2018

Primary Completion

July 20, 2020

Study Completion

July 27, 2020

Last Updated

February 9, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)