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临床试验/NCT07790679
NCT07790679招募中不适用

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

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Number and percentage of bacterial and fungal isolates resistant to each antibiotic tested at enrollment

研究概览

简要总结

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.

详细描述

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:

  1. To identify the bacterial and fungal pathogens isolated from patients with MOE at Sohag University Hospitals.
  2. 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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number and percentage of bacterial and fungal isolates resistant to each antibiotic tested at enrollment

时间窗: 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.

次要结局

  • Number and percentage of microbial isolates with antibiotic and antifungal resistance at enrollment(At time of enrollment, from July 2026 to July 2027)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Ashraf Mohamed

Prof. Mohamed AbdElkader Ahmed

Sohag University

研究点 (1)

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