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临床试验/NCT05431673
NCT05431673Unknown1 期

Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Assiut University0 个研究点目标入组 45 人开始时间: 2022年8月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
45
主要终点
Percentage of patients showing post treatment histopathologic resolution

研究概览

简要总结

The study is conducted To evaluate the Efficacy of Doxycycline (alone and in combination with Ciprofloxacin) as an alternative to the regular regimen in treating rhinoscleroma, especially for cases with contraindication to the use of one or more of the regularly used drugs.

详细描述

Rhinoscleroma is a chronic granulomatous disease endemic in many eastern countries including Egypt, Its causative agent is a gram-negative bacillus, Klebsiella rhinoscleromatis. Low socioeconomic populations are the most affected.. There are four known stages of the lesion. The first of which the 'Catarrhal stage' with purulent rhinorrhea, then there is the 'Atrophic stage' with a picture similar to that of atrophic rhinitis. The next is the 'Hypertrophic' or 'Granulomatous' stage where there are bluish red rubbery nodules in any part along the distribution of the disease, and eventually the 'Fibrotic' or 'Sclerotic' stage with stenosis deformity and loss of functions of the parts affected. Examples of commonly used drugs are 'Rifampicin' which is the most commonly used drug exhibits good results but the need for close monitoring for fear of toxicity is the only limitation to its use, Ciprofloxacin' is another Antibiotic with special efficacy as it has good tissue penetration & produces high concentrations in respiratory tract secretions. Recently 'Doxycycline' has been approved to be used in rhinoscleroma which has the advantage of not only easier dosing but also better patient compliance as it's used for a shorter course (6 weeks) compared to most other drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be included after confirmation by histopathological examination.
  • Patients presented in active stages of the disease.
  • Patients between 18-70 years.

排除标准

  • Any granulomatous lesion or features suggestive of rhinoscleroma associated with any other nasal lesions like syphilis, leprosy and tuberculosis were excluded.
  • Patients below 18 years and above 70 years.
  • Biopsy-negative cases.
  • Patients in Atrophic or Sclerotic Stages of the disease.

研究组 & 干预措施

Doxycycline

Active Comparator

• Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1]

干预措施: Doxycycline (Drug)

Doxycycline & Ciprofloxacin

Active Comparator

• Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) & Ciprofloxacin (250mg twice daily for 4 weeks).[1]

干预措施: Doxycycline (Drug)

Doxycycline & Ciprofloxacin

Active Comparator

• Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) & Ciprofloxacin (250mg twice daily for 4 weeks).[1]

干预措施: Ciprofloxacin (Drug)

Rifampicin

Active Comparator

• Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks)

干预措施: Rifampin (Drug)

结局指标

主要结局

Percentage of patients showing post treatment histopathologic resolution

时间窗: 8 months from the start of treatment

Comparing Histopathologic changes pre and post intervention for the 3 groups and the number of participants whose post treatment biopsy show histopathologic resolution will be measued as percentage to the total number of participants in each group

次要结局

  • Nasal Symptoms(8 months from the start of treatment)

研究者

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

Abdullah Mohamad Omar

Resident of otorhinolaryngology department

Assiut University

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