Rhinoscleroma
Conditions
Keywords
Rhinoscleroma, Gemifloxacin, Ciprofloxacin
Brief summary
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma
Detailed description
Rhinoscleroma is a chronic specific granulomatous inflammation affecting nose in 95-100% but can affect any part of respiratory tract.(1) It is an endemic disease in Egypt. It is endemic as well in sporadic areas worldwide including Central America, Chili, Central Africa, India, Indonesia and Middle East countries.(2) It is completely eradicated from the developed communities. If not treated early, the disease progresses to the final sclerotic phase where permanent complications including nasal deformities, anosmia, dysphonia, dysphagia and stridor could happen.(3-5) Of the wide treatments range (antibiotic combinations, cytostatic drugs, radiation, and laser), none is ideal. The causative organism is resistant to most antibiotics and, being intracellular, is not always exposed to sufficient concentrations of drug. A clinical cure is hard to identify because the end-stage is mucosal fibrosis which, even without active infection, interferes with normal function of the upper respiratory tract. The fibrosed mucosa, especially in crusts, can become secondarily infected with bacteria, which may include klebsiella.(6) Rifampin (7), streptomycin (8), ciprofloxacin (5) and levofloxacin (9) have been used in treatment of rhinoscleroma. Most patients are from a low socioeconomic group and cannot afford the price of antibiotics to which klebsiella is susceptible. (6) The usual regimen given for free by the Ministry of Health in Egypt in histologically positive cases is Rifampicin 300 mg twice daily for six months (based on a nasal biopsy and documented as a Tuberculosis, not rhinoscleroma, to allow free delivery of the medication) then another biopsy is taken to identify if cure or not. If not, Rifampicin is given for another six months and so on. Unfortunately, due to the high level of antimicrobial resistance, poor patients' compliance, and drugs side effects, the treatment failure rate is increasing. So there is a real need for an alternative drug that is effective, safe and has a short treatment course. Gemifloxacin is a new fluoroquinolone that has bactericidal activity. It has good intracellular penetration and low toxicity.(10) It is more potent than ciprofloxacin, ofloxacin and levofloxacin.(11)
Interventions
DRUGGemifloxacin
Gemifloxacin 320Mg Oral Tablet once daily
DRUGCiprofloxacin
cipro 750 tablet twice daily
DRUGRifampicin
Rifampicin 150Mg Capsule twice daily
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age above 18 years 2. Active rhinoscleroma proved both clinically and histopathologically
Exclusion criteria
1. Patients younger than 18 years old. 2. inactive Rhinoscleroma 3. Contraindication to treatment severe renal or hepatic impairment 4. Refusal of enrollment in the research by the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical examination., nasal crustation, | monthly evaluation for 6 months | nasal crusting, O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6) |
| clinical examination purulent secretions | monthly evaluation for 6 months | purulent secretions (O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6) |
| • Full ENT history | monthly evaluation for 6 months | purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction |
Countries
Egypt
Contacts
Primary Contactasmaa ahmed, resident
Outcome results
None listed