An observational study in Malignant Otitis Externa, sponsored by Sohag University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Sohag University · Observational
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.
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:
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.
80 studies on the registry are indexed under Otitis; 10 are open to participants now.
This study's planned enrollment of 40 is below the median of 177 across 26 observational studies indexed under Otitis.
Browse Otitis studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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Patients diagnosed with Malignant Otitis Externa presenting to the ENT department at Sohag University Hospitals
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: At time of enrollment, from July 2026 to July 2027
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.
Time frame: At time of enrollment, from July 2026 to July 2027
Plan to share: 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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