Chronic Suppurative Otitis Media Microbiology

Microbial Colonization Clinical Trial

Official title:

Microbiology of Chronic Suppurative Otitis Media: Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424704
• Other study ID #: 2024/145
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Selcuk University
• Contact: Burcu Tugba Aldora
• Phone: +905437608870
• Email: etikselcuk[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholesteatoma
• Communicable Diseases
• Infections
• Microbial Colonization
• Otitis
• Otitis Media
• Otitis Media, Suppurative

Intervention

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-ß-naphthylamide), oxidase test, IMViC test, lactophenol cotton blue, etc.] and VITEK 2 (bioMerieux, France).

Locations

Country	Name	City	State
Turkey	Bulent ULUSOY	Konya	Selcuklu
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiology of chronic suppurative otitis media	Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma	2024-2026 (24 months)
Secondary	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.	2024-2026 (24 months)