Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-21

Study Completion Date

2023-07-31

Brief Summary

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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.

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Detailed Description

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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

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Rhinoscleroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Doxycycline

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

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

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

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).\[1\]

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

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

Ciprofloxacin

Intervention Type DRUG

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

Rifampicin

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

Group Type ACTIVE_COMPARATOR

Rifampin

Intervention Type DRUG

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

Interventions

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Doxycycline

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

Intervention Type DRUG

Ciprofloxacin

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

Intervention Type DRUG

Rifampin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No