Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Doxycycline • Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1] |
Drug: Doxycycline
Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
|
Active Comparator: Doxycycline & Ciprofloxacin • 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
Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
Drug: Ciprofloxacin
Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma
|
Active Comparator: Rifampicin • Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks) |
Drug: Rifampin
Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients showing post treatment histopathologic resolution [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
Secondary Outcome Measures
- Nasal Symptoms [8 months from the start of treatment]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients will be included after confirmation by histopathological examination.
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Patients presented in active stages of the disease.
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Patients between 18-70 years.
Exclusion Criteria:
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Any granulomatous lesion or features suggestive of rhinoscleroma associated with any other nasal lesions like syphilis, leprosy and tuberculosis were excluded.
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Patients below 18 years and above 70 years.
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Biopsy-negative cases.
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Patients in Atrophic or Sclerotic Stages of the disease.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Director: Ahmed AbdelAleem, PhD, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- Abou-Seif SG, Baky FA, el-Ebrashy F, Gaafar HA. Scleroma of the upper respiratory passages: a CT study. J Laryngol Otol. 1991 Mar;105(3):198-202.
- Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2.
- Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6.
- Jage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5
- Kallapa S, Sarkar SR, Shankar MG. Effectiveness of ciprofloxacin vs. doxycycline in treatment of rhinoscleroma- A case-control study. J. Evid. Based Med. Healthc. 2017; 4(20), 1165-1168
- Menzies D, Benedetti A, Paydar A, Martin I, Royce S, Pai M, Vernon A, Lienhardt C, Burman W. Effect of duration and intermittency of rifampin on tuberculosis treatment outcomes: a systematic review and meta-analysis. PLoS Med. 2009 Sep;6(9):e1000146. doi: 10.1371/journal.pmed.1000146. Epub 2009 Sep 15. Review.
- Doxycycline in Rhinoscleroma