Rhinoscleroma Clinical Trial
Official title:
Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma
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)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00747461 -
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
|
Phase 4 | |
| Not yet recruiting |
NCT05431673 -
Efficacy Of Doxycycline & Versus Rifampin In Treatment Of Rhinoscleroma
|
Phase 1 |