Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Assiut University

Status and phase: Not yet enrolling; Phase 1

Conditions: Rhinoscleroma

Treatments: Drug: Doxycycline; Drug: Rifampin; Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05431673

Doxycycline in Rhinoscleroma

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Doxycycline

Active Comparator group

Description:

• Subjects in this group will be treated with Doxycycline (100mg/day for 8 weeks).\[1\]

Treatment:

Drug: Doxycycline

Doxycycline & Ciprofloxacin

Active Comparator group

Description:

• Subjects in this group will be treated with combination of Doxycycline (100mg/day for 8 weeks) \& Ciprofloxacin (250mg twice daily for 4 weeks).\[1\]

Treatment:

Drug: Ciprofloxacin

Drug: Doxycycline

Rifampicin

Active Comparator group

Description:

• Subjects in this group will be treated with Rifampicin (600mg/day for 6 weeks)

Treatment:

Drug: Rifampin