Microbiological Screening Of Malignant Otitis Externa Patients Presenting at Sohag University Hospitals

NCT07790679 | Recruiting

• 1 other identifier: Soh-Med-26-7-1MS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The goal is to determine the most common pathogens and their antibiotic resistance patterns to help doctors choose the best treatment.

Conditions

Malignant Otitis Externa

Keywords

Malignant Otitis Externa; MOE; Ear Infection; Bacterial culture; fungal culture; Antibiotic resistance; pseudomonas; sohag; egypt

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At time of enrollment, from July 2026 to July 2027

Study Arms (1)

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.

Other: ear swab and susceptibility testing

Interventions

ear swab and susceptibility testing OTHER

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.

MOE patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Malignant Otitis Externa presenting to the ENT department at Sohag University Hospitals

You may qualify if:

• Patients clinically diagnosed with MOE based on severe otalgia, external auditory canal inflammation ± granulation tissue.
• Patients with risk factors such as DM, Immunocompromised patients.

You may not qualify if:

• Post-operative ear cases (recent ear surgery).
• Patients with external auditory canal tumors.
• Patient refusal

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospitals

Sohag, Sohag Governorate, 82524, Egypt

RECRUITING

Related Publications (1)

• Authors: Chandler JR. Article Title: Malignant external otitis: further considerations. Journal Name: Laryngoscope. Publication Date: 1968 Volume: 78 Pages: 372-376

  BACKGROUND

MeSH Terms

Conditions

Otitis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Osama Mohamed Rashad

  Department of Otorhinolaryngology, Sohag University Hospitals

  STUDY CHAIR

Central Study Contacts

Omar Ashraf Mohamed

CONTACT

+201065563874; omarashraf833@gmail.com

Mohamed AbdElkader Ahmed

CONTACT

+201005051988

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mohamed AbdElkader Ahmed

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)