Exploring the Risk Factors of Otomycosis: A Case-Control Study

August 7, 2024 updated by: Zhongshan Hospital Xiamen University

The goal of this observational study is to explore the risk factors of fungal otitis externa in the fungal otitis externa patients The main question it aims to answer is:

What behaviors lead to the occurrence of fungal otitis externa? Participants will complete a detailed questionnaire survey. If there is a comparison group: Researchers will compare the healthy group and the disease group to see if there are any differences.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • Zhongshan Hospital of Xiamen University
        • Contact:

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

Yes

Sampling Method

Probability Sample

Study Population

Our institution is a tertiary first-class comprehensive hospital. Both the disease group and the control group are seen and screened at our facility

Description

Inclusion Criteria:

  • Symptoms in the case group include tinnitus, ear fullness or blockage, itching, ear pain, discharge, and hearing loss. Physical examination reveals the presence of hyphae, scabs, secretions, masses, pus, red skin, erosion, swelling, or granulation in the ear canal. Laboratory fungal cultures must be positive. The control group does not have the aforementioned ear symptoms and has not sought medical attention for ear-related symptoms.

Exclusion Criteria:

  • Patients with otitis media, tympanic membrane perforation, or post-radiotherapy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group
this group consists of patients who have been diagnosed with otomycosis.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.
Other: exposures
exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.
Control Group
This group includes healthy individuals who have not been diagnosed with otomycosis during medical examinations.Observational exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.
Other: exposures
exposures: Ear cleaning, swimming, wearing earphones, diabetes, immunosuppression, antibiotic ear drops, narrowing of the external auditory canal, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odds Ratio
Time Frame: 1month
The ratio of exposed to non-exposed individuals in the case group divided by the ratio of exposed to non-exposed individuals in the control group.
1month

Collaborators and Investigators

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

Sponsor

Zhongshan Hospital Xiamen University

Investigators

  • Principal Investigator: Chunsheng Ye, MD, Zhongshan Hospital Xiamen University

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 1, 2024

Primary Completion (Actual)

August 7, 2024

Study Completion (Estimated)

August 15, 2024

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

July 27, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xmzsyyky-2024-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

The data will be available within six months after the completion of the study and will remain accessible for at least ten years.

IPD Sharing Access Criteria

The data will be open to peer-reviewed researchers. Researchers requesting access to the data must submit a research proposal and pass our review process. All data requestors must also adhere to a data use agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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