Otitis Media, Suppurative ChronicNCT06424704
Chronic Suppurative Otitis Media Microbiology
An observational study of Otitis Media, Suppurative Chronic and Cholesteatoma, run by Selcuk University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Otitis Media, Suppurative Chronic, Cholesteatoma, Microbial Colonization
- What is being tested?
- Microbiological culture
- How many people
- 110 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2024to May 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Patients diagnosed with chronic suppurative otitis media
- Patients over 18 years of age
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bulent ULUSOY
Konya, Selcuklu, 42100
Bulent ulusoy
Selcuk University
Konya, Selcuklu, 42100
About this study
Official title: Microbiology of Chronic Suppurative Otitis Media: Prospective Study
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.
- Being tested
- Microbiological culture
- Keywords
- Chronic suppurative otitis media, Cholesteatoma, Ear discharge
- Medical subject headings
- Otitis Media, Cholesteatoma, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological cultureDiagnostic test
Also called Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Microbiological culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiology of chronic suppurative otitis media
Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma
Measured: 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.
Measured: 2024-2026 (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 May 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Otitis Media, Suppurative ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bulent Ulusoy, Selcuk University
- Investigators
- Bulent Ulusoy, MD, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424704
- Sponsor's protocol ID
- 2024/145
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 37727177Verhoeff 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology of Chronic Suppurative Otitis Media: Prospective Study
- ClinicalTrials.gov ID
- NCT06424704
- Acronym / sponsor ID
- 2024/145
- Keywords
- Chronic suppurative otitis media, Cholesteatoma, Ear discharge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic suppurative otitis media with cholesteatoma (Chole) | – | Diagnostic Test: Microbiological culturePatients 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. |
| Chronic suppurative otitis media without cholesteatoma (CSOM) | – | Diagnostic Test: Microbiological cultureThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with chronic suppurative otitis media
- Patients over 18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological cultureAlso: Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).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). | Diagnostic test | Chronic suppurative otitis media with cholesteatoma (Chole), Chronic suppurative otitis media without cholesteatoma (CSOM) |
Primary outcome
Microbiology of chronic suppurative otitis media
Time frame: 2024-2026 (24 months)
Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma
1 secondary outcome
Antibiotic susceptibility in chronic suppurative otitis media
Time frame: 2024-2026 (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 37727177Khairkar 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.
- Background: PubMed 16198004Verhoeff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Ulusoy, MD principal investigator
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, Suppurative Chronic and Cholesteatoma, run by Selcuk University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Burcu Tuğba Aldora (+905437608870, etikselcuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiology of chronic suppurative otitis media (time frame: 2024-2026 (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06424704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.