Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Rhinoscleroma Clinical Trial

Official title:

Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05431673
• Other study ID #: Doxycycline in Rhinoscleroma
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 21, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: Abdullah Omar, Bachelor
• Phone: 00201125073607
• Email: Dramomo95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinoscleroma

Intervention

Drug:
• Doxycycline
Doxycycline 100mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma
• Ciprofloxacin
Ciprofloxacin 500mg/day for 4 weeks used as single or combination treatment for Rhinoscleroma
• Rifampin
Rifampin 600mg/day for 6 weeks used as single or combination treatment for Rhinoscleroma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Abou-Seif SG, Baky FA, el-Ebrashy F, Gaafar HA. Scleroma of the upper respiratory passages: a CT study. J Laryngol Otol. 1991 Mar;105(3):198-202. — View Citation

Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. — View Citation

Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6. — View Citation

Jage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5

Kallapa S, Sarkar SR, Shankar MG. Effectiveness of ciprofloxacin vs. doxycycline in treatment of rhinoscleroma- A case-control study. J. Evid. Based Med. Healthc. 2017; 4(20), 1165-1168

Menzies D, Benedetti A, Paydar A, Martin I, Royce S, Pai M, Vernon A, Lienhardt C, Burman W. Effect of duration and intermittency of rifampin on tuberculosis treatment outcomes: a systematic review and meta-analysis. PLoS Med. 2009 Sep;6(9):e1000146. doi: 10.1371/journal.pmed.1000146. Epub 2009 Sep 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients showing post treatment histopathologic resolution	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	8 months from the start of treatment
Secondary	Nasal Symptoms	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)	8 months from the start of treatment