ClinicalTrials.gg
Not yet recruitingNCT06424704Updated May 22, 2024

Chronic Suppurative Otitis Media Microbiology

An observational study in Otitis Media, Suppurative Chronic, Cholesteatoma and Microbial Colonization, sponsored by Selcuk University. Not yet recruiting at 2 sites in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Selcuk University · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Otitis Media, Suppurative Chronic
  • Cholesteatoma
  • Microbial Colonization

Keywords

  • Chronic suppurative otitis media
  • Cholesteatoma
  • Ear discharge
03

In context

Otitis Media

241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.

This study's planned enrollment of 110 is below the median of 150 across 57 observational studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testMicrobiological 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).

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

06

What researchers measure

Primary outcomes

  1. Microbiology of chronic suppurative otitis media

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

    Time frame: 2024-2026 (24 months)

Secondary outcomes

  1. Antibiotic susceptibility in chronic suppurative otitis media

    Investigation of antibiotic susceptibility and resistance in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma.

    Time frame: 2024-2026 (24 months)

07

Study locations

2 sites
  • Bulent ULUSOY
    Konya, Selcuklu 42100, Turkey
    • Bulent ulusoy · Contact
  • Selcuk University
    Konya, Selcuklu 42100, Turkey
08

References and documents

Publications

  • 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. PubMed 37727177 ↗
  • 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. PubMed 16198004 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06424704
Lead sponsor
Selcuk University
Responsible party
Bulent Ulusoy (Selcuk University Faculty of Medicine, Selcuk University) — Principal investigator
First posted
May 22, 2024
Start date
May 15, 2024 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
May 22, 2024

Study contacts

Burcu Tuğba Aldora
Contact
etikselcuk@gmail.com
+905437608870
Bulent Ulusoy, MD
principal investigator · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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