Clinical trial NCT06424704: Chronic Suppurative Otitis Media Microbiology
Official title: Microbiology of Chronic Suppurative Otitis Media: Prospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Otitis Media, Suppurative Chronic
Cholesteatoma
Microbial Colonization
Keywords: Chronic suppurative otitis media
Cholesteatoma
Ear discharge
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiology of chronic suppurative otitis media
timeFrame: 2024-2026 (24 months)
Secondary outcomes:
measure: Antibiotic susceptibility in chronic suppurative otitis media
timeFrame: 2024-2026 (24 months)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Bulent ULUSOY
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Bulent Ulusoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.