Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhinoscleroma
• Intervention / Treatment: Drug: Doxycycline; Drug: Ciprofloxacin; Drug: Rifampin

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Abdullah Omar, Bachelor; Phone Number: 00201125073607; Email: Dramomo95@gmail.com
• Study Contact Backup: Name: Mohammed Roshdy, PhD; Phone Number: 00201005630198; Email: mohammedroushdy@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed AbdelAleem, PhD, Assiut University

Publications and helpful links

General Publications

• 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
• 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. doi: 10.1017/s0022215100115348.
• Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. doi: 10.1258/0022215011907028.
• Cone LA, Barton SM, Woodard DR. Treatment of scleroma with ceforanide. Arch Otolaryngol Head Neck Surg. 1987 Apr;113(4):374-6. doi: 10.1001/archotol.1987.01860040036012.
• Jage M, Rambhia KD, Khopkar US. Efficacy of doxycyclin monotherapy in treating rhinoscleroma. Indian J Drugs Dermatol 2018;4:23-5
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 21, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: doxycycline
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Nose Diseases; Skin Diseases, Bacterial; Enterobacteriaceae Infections; Klebsiella Infections; Rhinoscleroma; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Antiprotozoal Agents; Antiparasitic Agents; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antimalarials; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP1A2 Inhibitors; Doxycycline; Rifampin; Ciprofloxacin
• Other Study ID Numbers: Doxycycline in Rhinoscleroma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No