Malignant Otitis ExternaMOE ScreeningNCT07790679
Microbiological Screening Of Malignant Otitis Externa Patients Presenting at Sohag University Hospitals
An observational study of Malignant Otitis Externa, run by Sohag University at 1 site in Egypt.
Trial summary
This is a prospective study to identify the bacterial and fungal organisms causing Malignant Otitis Externa (MOE) in patients presenting to Sohag University Hospitals. Ear swabs will be collected from patients diagnosed with MOE and sent to the microbiology lab for culture and sensitivity testing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Otitis Externa
- What is being tested?
- ear swab and susceptibility testing
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with Malignant Otitis Externa presenting to the ENT department at Sohag University Hospitals
Who may be able to join
- Patients clinically diagnosed with MOE based on severe otalgia, external auditory canal inflammation ± granulation tissue.
- Patients with risk factors such as DM, Immunocompromised patients.
Who cannot join
- Post-operative ear cases (recent ear surgery).
- Patients with external auditory canal tumors.
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed AbdElkader Ahmed contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospitals
Sohag, Sohag Governorate, 82524
Omar Ashraf Mohamed, +201065563874, omarashraf833@gmail.com
Doaa Mohamed Gad, +201095874485
About this study
This is a prospective study to identify the bacterial and fungal organisms causing Malignant Otitis Externa (MOE) in patients presenting to Sohag University Hospitals. Ear swabs will be collected from patients diagnosed with MOE and sent to the microbiology lab for culture and sensitivity testing. The goal is to determine the most common pathogens and their antibiotic resistance patterns to help doctors choose the best treatment.
Read the detailed description
Malignant Otitis Externa is a severe infection of the external ear canal that can spread to the skull base. It is most common in elderly diabetic patients. There is limited data about the microbiological profile of MOE patients in Upper Egypt.
Objectives:
- To identify the bacterial and fungal pathogens isolated from patients with MOE at Sohag University Hospitals.
- To determine the antibiotic susceptibility patterns of the isolated organisms.
Methods:
This is a prospective cross-sectional study. Patients diagnosed with MOE in the ENT department at Sohag University Hospitals will be included. An ear swab will be taken from each patient under sterile conditions and sent to the microbiology laboratory. Samples will undergo culture, identification, and antibiotic sensitivity testing according to standard lab protocols. Patient demographic data and clinical findings will also be recorded.
Expected Outcome:
To provide local data on the causative organisms of MOE and their resistance patterns to guide empirical antibiotic therapy.
- Conditions
- Malignant Otitis Externa
- Being tested
- ear swab and susceptibility testing
- Keywords
- Malignant Otitis Externa, MOE, Ear Infection, Bacterial culture, fungal culture, Antibiotic resistance, pseudomonas, sohag, egypt
- Medical subject headings
- Otitis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear swab and susceptibility testingOther
For all enrolled patients, an ear swab will be collected for bacterial and fungal culture and antibiotic susceptibility testing. This is a diagnostic procedure only and is not a therapeutic intervention. No drugs are administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| MOE patients | Prospective observational cohort of patients aged 18 years and older clinically diagnosed with Malignant Otitis Externa. All patients will undergo clinical examination and ear swab for bacterial and fungal culture. Enrollment from July 2026 to July 2027. Receives: Other: ear swab and susceptibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of bacterial and fungal isolates resistant to each antibiotic tested at enrollment
Measure: Antibiotic susceptibility testing will be performed on all isolates obtained from patients with Malignant Otitis Externa according to CLSI guidelines.
Metric: Count and percentage of resistant isolates for each antibiotic.
Measured: At time of enrollment, from July 2026 to July 2027
Secondary outcomes (1)
Number and percentage of microbial isolates with antibiotic and antifungal resistance at enrollment
Microbial isolates including bacteria and fungi will be obtained from patients with Malignant Otitis Externa.
Antimicrobial susceptibility testing will be performed for bacteria and antifungal susceptibility testing for fungi according to CLSI guidelines.
Metric: Count and percentage of resistant isolates reported separately for bacterial and fungal organisms for each antimicrobial agent tested.
Measured: At time of enrollment, from July 2026 to July 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Otitis ExternaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ashraf Mohamed, Sohag University
- Investigators
- Osama Mohamed Rashad, Study chair, Department of Otorhinolaryngology, Sohag University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790679
- Sponsor's protocol ID
- Soh-Med-26-7-1MS
- Acronym
- MOE Screening
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect patient privacy and confidentiality in accordance with institutional policy and ethical approval from Sohag University.
Publications
Authors: Chandler JR. Article Title: Malignant external otitis: further considerations. Journal Name: Laryngoscope. Publication Date: 1968 Volume: 78 Pages: 372-376
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Screening Of Malignant Otitis Externa Patients Presenting at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT07790679
- Acronym / sponsor ID
- MOE Screening / Soh-Med-26-7-1MS
- Conditions
- Malignant Otitis Externa
- Keywords
- Malignant Otitis Externa, MOE, Ear Infection, Bacterial culture, fungal culture, Antibiotic resistance, pseudomonas, sohag
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 27 Aug 2026 (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 is a prospective study to identify the bacterial and fungal organisms causing Malignant Otitis Externa (MOE) in patients presenting to Sohag University Hospitals. Ear swabs will be collected from patients diagnosed with MOE and sent to the microbiology lab for culture and sensitivity testing. The goal is to determine the most common pathogens and their antibiotic resistance patterns to help doctors choose the best treatment.
Detailed description
Malignant Otitis Externa is a severe infection of the external ear canal that can spread to the skull base. It is most common in elderly diabetic patients. There is limited data about the microbiological profile of MOE patients in Upper Egypt.
Objectives:
- To identify the bacterial and fungal pathogens isolated from patients with MOE at Sohag University Hospitals.
- To determine the antibiotic susceptibility patterns of the isolated organisms.
Methods:
This is a prospective cross-sectional study. Patients diagnosed with MOE in the ENT department at Sohag University Hospitals will be included. An ear swab will be taken from each patient under sterile conditions and sent to the microbiology laboratory. Samples will undergo culture, identification, and antibiotic sensitivity testing according to standard lab protocols. Patient demographic data and clinical findings will also be recorded.
Expected Outcome:
To provide local data on the causative organisms of MOE and their resistance patterns to guide empirical antibiotic therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOE patients | – | Other: ear swab and susceptibility testingProspective observational cohort of patients aged 18 years and older clinically diagnosed with Malignant Otitis Externa. All patients will undergo clinical examination and ear swab for bacterial and fungal culture. Enrollment from July 2026 to July 2027. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Malignant Otitis Externa presenting to the ENT department at Sohag University Hospitals
Key inclusion criteria (2 listed)
- Patients clinically diagnosed with MOE based on severe otalgia, external auditory canal inflammation ± granulation tissue.
- Patients with risk factors such as DM, Immunocompromised patients.
Key exclusion criteria (3 listed)
- Post-operative ear cases (recent ear surgery).
- Patients with external auditory canal tumors.
- Patient refusal
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 |
|---|---|---|
| ear swab and susceptibility testingFor all enrolled patients, an ear swab will be collected for bacterial and fungal culture and antibiotic susceptibility testing. This is a diagnostic procedure only and is not a therapeutic intervention. No drugs are administered as part of this study. | Other | MOE patients |
Primary outcome
Number and percentage of bacterial and fungal isolates resistant to each antibiotic tested at enrollment
Time frame: At time of enrollment, from July 2026 to July 2027
Measure: Antibiotic susceptibility testing will be performed on all isolates obtained from patients with Malignant Otitis Externa according to CLSI guidelines. Metric: Count and percentage of resistant isolates for each antibiotic.
1 secondary outcome
Number and percentage of microbial isolates with antibiotic and antifungal resistance at enrollment
Time frame: At time of enrollment, from July 2026 to July 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- BackgroundAuthors: Chandler JR. Article Title: Malignant external otitis: further considerations. Journal Name: Laryngoscope. Publication Date: 1968 Volume: 78 Pages: 372-376
- Individual participant dataSharing planned: No. IPD will not be shared to protect patient privacy and confidentiality in accordance with institutional policy and ethical approval from Sohag University.
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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.
Mohamed AbdElkader Ahmed contact
Osama Mohamed Rashad study chair
Department of Otorhinolaryngology, Sohag University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Otitis Externa, run by Sohag University at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Ashraf Mohamed (+201065563874, omarashraf833@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of bacterial and fungal isolates resistant to each antibiotic tested at enrollment (time frame: At time of enrollment, from July 2026 to July 2027). 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 NCT07790679, which also lists 1 linked publication.
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 27 Aug 2026.