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NCT Number: NCT07790679

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed AbdElkader Ahmed

CONTACT

+201005051988

Omar Ashraf Mohamed

CONTACT

[email protected]

+201065563874

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Acronym: MOE Screening

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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