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Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05431673
Enrollment
45
Registered
2022-06-24
Start date
2022-08-21
Completion date
2023-07-31
Last updated
2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinoscleroma

Keywords

doxycycline

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.

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.

Interventions

DRUGDoxycycline

Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma

DRUGCiprofloxacin

Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma

DRUGRifampin

Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of patients showing post treatment histopathologic resolution8 months from the start of treatmentComparing 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

MeasureTime frameDescription
Nasal Symptoms8 months from the start of treatmentAll 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 1. mild symptoms 2. moderate symptoms 3. sever symptoms 4. 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)

Contacts

Primary ContactAbdullah Omar, Bachelor
Dramomo95@gmail.com00201125073607
Backup ContactMohammed Roshdy, PhD
mohammedroushdy@aun.edu.eg00201005630198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026