Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05431673
Collaborator
(none)
45
3
11.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma
Anticipated Study Start Date :
Aug 21, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Doxycycline

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

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

Active Comparator: 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]

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

Active Comparator: Rifampicin

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

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients showing post treatment histopathologic resolution [8 months from the start of treatment]

    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

Secondary Outcome Measures

  1. Nasal Symptoms [8 months from the start of treatment]

    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 mild symptoms moderate symptoms sever symptoms 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed AbdelAleem, PhD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdullah Mohamad Omar, Resident of otorhinolaryngology department, Assiut University
ClinicalTrials.gov Identifier:
NCT05431673
Other Study ID Numbers:
  • Doxycycline in Rhinoscleroma
First Posted:
Jun 24, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abdullah Mohamad Omar, Resident of otorhinolaryngology department, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022