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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline | Active Comparator | • Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).[1] |
|
| 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] |
|
| Rifampicin | Active Comparator | • Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma |
|
| 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 |
| 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
the total five-symptom score obtained will be the sum of the individual symptoms(0-20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdullah Omar, Bachelor | Contact | 00201125073607 | Dramomo95@gmail.com | |
| Mohammed Roshdy, PhD | Contact | 00201005630198 | mohammedroushdy@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed AbdelAleem, PhD | Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 2019806 | Background | 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. doi: 10.1017/s0022215100115348. | |
| 11244532 |
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| ID | Term |
|---|---|
| D012226 | Rhinoscleroma |
| ID | Term |
|---|---|
| D007710 | Klebsiella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002939 | Ciprofloxacin |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin
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| Ciprofloxacin | Drug | Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma |
|
| Rifampin | Drug | Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma |
|
| 8 months from the start of treatment |
| Background |
| Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. doi: 10.1258/0022215011907028. |
| 3814386 | Background | Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6. doi: 10.1001/archotol.1987.01860040036012. |
| Background | Jage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5 |
| 19753109 | Background | 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. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012141 | Respiratory Tract Infections |
| D012874 | Skin Diseases, Infectious |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |