Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Conditions
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Rhinoscleroma

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Ciprofloxacin
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be included after confirmation by histopathological examination. Patients presented in active stages of the disease. Patients between 18-70 years. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doxycycline<br>• Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1] | Drug: Doxycycline<br>* Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma<br>|
| Active Comparator: Doxycycline & Ciprofloxacin<br>• Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) & Ciprofloxacin (250mg twice daily for 4 weeks).[1] | Drug: Doxycycline<br>* Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma<br>Drug: Ciprofloxacin<br>* Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma<br>|
| Active Comparator: Rifampicin<br>• Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks) | Drug: Rifampin<br>* Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients showing post treatment histopathologic resolution | 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 | 8 months from the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Symptoms | All participants will be asked to score 5 nasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell and facial pain.) from 0 to 4. 0= no symptoms mild symptoms moderate symptoms sever symptoms very sever symptoms this score will be assessed at the screening visit & follow up visits at 8 weeks , 6 months. the total five-symptom score obtained will be the sum of the individual symptoms(0-20) | 8 months from the start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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doxycycline