## Protocol Section
### Identification Module
**NCT ID:** NCT06424704

**Brief Title:** Chronic Suppurative Otitis Media Microbiology

**Official Title:** Microbiology of Chronic Suppurative Otitis Media: Prospective Study

#### Organization Study ID Info
**ID:** 2024/145
#### Organization
**Class:** OTHER
**Full Name:** Selcuk University
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Selcuk University

#### Responsible Party

**Investigator Affiliation:** Selcuk University

**Investigator Full Name:** Bulent Ulusoy

**Investigator Title:** Selcuk University Faculty of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Otitis Media, Suppurative Chronic

- Cholesteatoma

- Microbial Colonization

**Keywords:**

- Chronic suppurative otitis media

- Cholesteatoma

- Ear discharge

### Design Module

#### Bio Spec

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

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 6 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Microbiological culture

**Label:** Chronic suppurative otitis media with cholesteatoma (Chole)

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Microbiological culture

**Label:** Chronic suppurative otitis media without cholesteatoma (CSOM)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Chronic suppurative otitis media with cholesteatoma (Chole)

- Chronic suppurative otitis media without cholesteatoma (CSOM)

**Description:** 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).

**Name:** Microbiological culture

**Other Names:**

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

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Microbiology of chronic suppurative otitis media

**Time Frame:** 2024-2026 (24 months)

#### Secondary Outcomes

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

**Measure:** Antibiotic susceptibility in chronic suppurative otitis media

**Time Frame:** 2024-2026 (24 months)

### Eligibility Module

**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

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** etikselcuk@gmail.com

**Name:** Burcu Tuğba Aldora

**Phone:** +905437608870

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Konya

**Contacts:**

***Contact 1:***

- **Name:** Bulent ulusoy

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Bulent ULUSOY

**State:** Selcuklu

**Zip:** 42100

**Location 2:**

**City:** Konya

**Country:** Turkey

**Facility:** Selcuk University

**State:** Selcuklu

**Zip:** 42100

#### Overall Officials

**Official 1:**

**Affiliation:** Selcuk University

**Name:** Bulent Ulusoy, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 37727177

**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.

**PMID:** 16198004

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007249

- Term: Inflammation

- ID: D000007642

- Term: Keratosis

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Suppurative

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Microbial Colonization

- ID: M12954

- Name: Otitis

- Relevance: HIGH

- As Found: Otitis

- ID: M12956

- Name: Otitis Media

- Relevance: HIGH

- As Found: Otitis Media

- ID: M16273

- Name: Suppuration

- Relevance: HIGH

- As Found: Suppurative

- ID: M12958

- Name: Otitis Media, Suppurative

- Relevance: HIGH

- As Found: Otitis Media, Suppurative

- ID: M6021

- Name: Cholesteatoma

- Relevance: HIGH

- As Found: Cholesteatoma

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M28268

- Name: Keratosis, Actinic

- Relevance: LOW

- As Found: Unknown

- ID: M10668

- Name: Keratosis

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

- ID: T1152

- Name: Cholesteatoma

- Relevance: HIGH

- As Found: Cholesteatoma

### Condition Browse Module - Meshes

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000013492

- Term: Suppuration

- ID: D000010035

- Term: Otitis Media, Suppurative

- ID: D000010031

- Term: Otitis

- ID: D000010033

- Term: Otitis Media

- ID: D000002781

- Term: Cholesteatoma

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: HIGH

- As Found: Initial

- ID: M4224

- Name: Antibiotics, Antitubercular

- Relevance: LOW

- As Found: Unknown

- ID: M11726

- Name: Methylene Blue

- Relevance: LOW

- As Found: Unknown

- ID: M5626

- Name: Catalase

- Relevance: LOW

- As Found: Unknown

- ID: M4712

- Name: Bacitracin

- Relevance: LOW

- As Found: Unknown

- ID: M6260

- Name: Coagulase

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000900

- Term: Anti-Bacterial Agents

### Misc Info Module

- Version Holder: 2024-05-31
