Chronic Suppurative Otitis Media Microbiology

NCT06424704 | Not Yet Recruiting

• 1 other identifier: 2024/145
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Otitis Media, Suppurative Chronic; Cholesteatoma; Microbial Colonization

Keywords

Chronic suppurative otitis media; Cholesteatoma; Ear discharge

Outcome Measures

Primary Outcomes (1)

• Microbiology of chronic suppurative otitis media

  Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma

  2024-2026 (24 months)

Secondary Outcomes (1)

• Antibiotic susceptibility in chronic suppurative otitis media

  2024-2026 (24 months)

Study Arms (2)

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

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

Interventions

Microbiological culture 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).

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

Chronic suppurative otitis media with cholesteatoma (Chole); Chronic suppurative otitis media without cholesteatoma (CSOM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with chronic suppurative otitis media
• Patients over 18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Bulent ULUSOY

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37727177 BACKGROUND

• 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.

  PMID: 16198004 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Culture samples taken from the ears of patients with chronic suppurative otitis media with cholesteatoma and chronic suppurative otitis media without cholesteatom.

MeSH Terms

Conditions

Otitis Media; Cholesteatoma; Communicable Diseases

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bulent Ulusoy, MD

  Selcuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burcu Tuğba Aldora

CONTACT

+905437608870; etikselcuk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Selcuk University Faculty of Medicine

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 22, 2024
• Study Start: May 15, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)