NCT05431673

Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinoscleroma

Interventions

Type	Name	Description
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
DRUG	Rifampin	Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma

Timeline

• Start date: 2022-08-21
• Primary completion: 2023-06-30
• Completion: 2023-07-31
• First posted: 2022-06-24
• Last updated: 2022-07-07