Chronic Suppurative Otitis Media Microbiology

NCT ID: NCT06424704

Last Updated: 2024-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Otitis Media, Suppurative Chronic Cholesteatoma Microbial Colonization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Microbiological culture

Intervention Type DIAGNOSTIC_TEST

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).

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.

Microbiological culture

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Bulent Ulusoy

Selcuk University Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bulent Ulusoy, MD

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

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Bulent ULUSOY

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Burcu Tuğba Aldora

Role: CONTACT

+905437608870

Facility Contacts

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Bulent ulusoy

Role: primary

References

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Khairkar M, Deshmukh P, Maity H, Deotale V. Chronic Suppurative Otitis Media: A Comprehensive Review of Epidemiology, Pathogenesis, Microbiology, and Complications. Cureus. 2023 Aug 18;15(8):e43729. doi: 10.7759/cureus.43729. eCollection 2023 Aug.

Reference Type BACKGROUND
PMID: 37727177 (View on PubMed)

Verhoeff M, van der Veen EL, Rovers MM, Sanders EA, Schilder AG. Chronic suppurative otitis media: a review. Int J Pediatr Otorhinolaryngol. 2006 Jan;70(1):1-12. doi: 10.1016/j.ijporl.2005.08.021. Epub 2005 Sep 27.

Reference Type BACKGROUND
PMID: 16198004 (View on PubMed)

Other Identifiers

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2024/145

Identifier Type: -

Identifier Source: org_study_id

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