Chronic Suppurative Otitis Media Microbiology

May 16, 2024 updated by: Bulent Ulusoy, Selcuk University

Microbiology of Chronic Suppurative Otitis Media: Prospective Study

This study is planned to reveal the microbiological agents and drug sensitivities to these agents in patients diagnosed with chronic suppurative otitis media who complain of ear discharge.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with complaints of ear discharge and who were diagnosed with chronic suppurative otitis media will be included in the study. Patients will be divided into two groups: CSOM with cholesteatoma and CSOM without cholesteatoma. One hundred ten patients from each group will be included in the study. After a comprehensive medical history is taken for each patient, the patient's external auditory canal will be cleaned with sterile aspirators. A sterile culture will be taken from the discharge of the ear and sent to microbiology. With the data obtained from microbiological examination, pathogens will be classified as gram-positive, gram-negative, anaerobic, and fungal and examined according to monomicrobial and polymicrobial growth. Antibiotic susceptibility tests will be conducted to determine the effectiveness of antibiotics against the bacteria causing the infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42100
        • Selcuk University
      • Konya, Selcuklu, Turkey, 42100
        • Bulent ULUSOY
        • Contact:
          • Bulent ulusoy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will include patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases & Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media.

Description

Inclusion Criteria:

  1. Patients diagnosed with chronic suppurative otitis media
  2. Patients over 18 years of age

Exclusion Criteria:

  1. Chronic nonsuppurative otitis media patients
  2. Patients diagnosed with external ear canal/middle ear malignancy
  3. Patients who take immunosuppressive drugs
  4. Immunosuppressive patients
  5. Patients who used antibiotics (topical-systemic) in the last week

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chronic suppurative otitis media with cholesteatoma (Chole)
Patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases & Head and Neck Surgery with complaints of ear discharge and were diagnosed with chronic suppurative otitis media with cholesteatoma were included in the study.
Diagnostic test: Microbiological culture
Samples taken from chronic suppurative otitis media patients in the Medical Microbiology Laboratory of Selçuk University Faculty of Medicine will be planted in 5% sheep blood Columbia agar, eosin methylene blue agar and saboraud dextrose agar, and the media will be incubated at 37oC for 24-48 hours. Growing bacteria and fungi were examined using traditional methods [Gram staining, catalase test, coagulase test, bacitracin disk, PYR test (L-pyrrolidonyl-β-naphthylamide), oxidase test, IMViC test, lactophenol cotton blue, etc.] and VITEK 2 (bioMerieux, France).
Other Names:
  • Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).
Chronic suppurative otitis media without cholesteatoma (CSOM)
The study included patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases & Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media without cholesteatoma.
Diagnostic test: Microbiological culture
Samples taken from chronic suppurative otitis media patients in the Medical Microbiology Laboratory of Selçuk University Faculty of Medicine will be planted in 5% sheep blood Columbia agar, eosin methylene blue agar and saboraud dextrose agar, and the media will be incubated at 37oC for 24-48 hours. Growing bacteria and fungi were examined using traditional methods [Gram staining, catalase test, coagulase test, bacitracin disk, PYR test (L-pyrrolidonyl-β-naphthylamide), oxidase test, IMViC test, lactophenol cotton blue, etc.] and VITEK 2 (bioMerieux, France).
Other Names:
  • Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiology of chronic suppurative otitis media
Time Frame: 2024-2026 (24 months)
Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma
2024-2026 (24 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antibiotic susceptibility in chronic suppurative otitis media
Time Frame: 2024-2026 (24 months)
Investigation of antibiotic susceptibility and resistance in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma.
2024-2026 (24 months)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bulent Ulusoy, MD, Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/145

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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