Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma

NCT05431673 | Unknown Phase 1

• 1 other identifier: Doxycycline in Rhinoscleroma
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinoscleroma

Keywords

doxycycline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Nasal Symptoms

  8 months from the start of treatment

Study Arms (3)

Doxycycline

ACTIVE COMPARATOR

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

Drug: Doxycycline

Doxycycline & Ciprofloxacin

ACTIVE COMPARATOR

• 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; Drug: Ciprofloxacin

Rifampicin

ACTIVE COMPARATOR

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

Drug: Rifampin

Interventions

Doxycycline DRUG

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

Doxycycline; Doxycycline & Ciprofloxacin

Ciprofloxacin DRUG

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

Doxycycline & Ciprofloxacin

Rifampin DRUG

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

Rifampicin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included after confirmation by histopathological examination.
• Patients presented in active stages of the disease.
• Patients between 18-70 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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

  BACKGROUND

• 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.

  PMID: 2019806 BACKGROUND

• Badia L, Lund VJ. A case of rhinoscleroma treated with ciprofloxacin. J Laryngol Otol. 2001 Mar;115(3):220-2. doi: 10.1258/0022215011907028.

  PMID: 11244532 BACKGROUND

• 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.

  PMID: 3814386 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19753109 BACKGROUND

MeSH Terms

Conditions

Rhinoscleroma

Interventions

Doxycycline; Ciprofloxacin; Rifampin

Condition Hierarchy (Ancestors)

Klebsiella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Respiratory Tract Infections; Skin Diseases, Infectious; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds

Study Officials

• Ahmed AbdelAleem, PhD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Abdullah Omar, Bachelor

CONTACT

00201125073607; Dramomo95@gmail.com

Mohammed Roshdy, PhD

CONTACT

00201005630198; mohammedroushdy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of otorhinolaryngology department

Model Details: 3 Groups A will receive Doxycycline B will receive Ciprofloxacin and Doxycycline C will receive Rifampin

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: June 24, 2022
• Study Start: August 21, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07