Clinical trial NCT03326050: Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma
Official title: Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Rhinoscleroma
Keywords: Rhinoscleroma
Gemifloxacin
Ciprofloxacin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: clinical examination., nasal crustation,
timeFrame: monthly evaluation for 6 months
measure: clinical examination purulent secretions
timeFrame: monthly evaluation for 6 months
measure: • Full ENT history
timeFrame: monthly evaluation for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Asmaa Ahmed
Study officials:
affiliation: assiut yunveristy
name: Ahmed mohamed, lecturer
role: STUDY_DIRECTOR
References:
citation: Ahmed AR, El-Badawy ZH, Mohamed IR, Abdelhameed WA. Rhinoscleroma: a detailed histopathological diagnostic insight. Int J Clin Exp Pathol. 2015 Jul 1;8(7):8438-45. eCollection 2015.
citation: The Editors. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-396. doi: 10.1099/0022-1317-49-5-395. No abstract available.
citation: Zhong Q, Guo W, Chen X, Ni X, Fang J, Huang Z, Zhang S. Rhinoscleroma: a retrospective study of pathologic and clinical features. J Otolaryngol Head Neck Surg. 2011 Apr;40(2):167-74.
citation: Fawaz S, Tiba M, Salman M, Othman H. Clinical, radiological and pathological study of 88 cases of typical and complicated scleroma. Clin Respir J. 2011 Apr;5(2):112-21. doi: 10.1111/j.1752-699X.2010.00207.x.
citation: Bailhache A, Dehesdin D, Francois A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41.
citation: Borgstein J, Sada E, Cortes R. Ciprofloxacin for rhinoscleroma and ozena. Lancet. 1993 Jul 10;342(8863):122. doi: 10.1016/0140-6736(93)91329-k. No abstract available.
citation: Gamea AM, el-Tatawi FA. The effect of rifampicin on rhinoscleroma: an electron microscopic study. J Laryngol Otol. 1990 Oct;104(10):772-7. doi: 10.1017/s002221510011388x.
citation: Toppozada HH, Gaafar HA. The effect of streptomycin and irradiation on rhinoscleroma (electron microscopic study). J Laryngol Otol. 1986 Jul;100(7):809-15. doi: 10.1017/s0022215100100118.
citation: Pound MW, Fulton KB, Chima CO. Successful treatment of Klebsiella rhinoscleromatis bacteremia with levofloxacin. Pharmacotherapy. 2007 Jan;27(1):161-3. doi: 10.1592/phco.27.1.161.
citation: Saravolatz LD, Leggett J. Gatifloxacin, gemifloxacin, and moxifloxacin: the role of 3 newer fluoroquinolones. Clin Infect Dis. 2003 Nov 1;37(9):1210-5. doi: 10.1086/378809. Epub 2003 Oct 2.
citation: Hoban DJ, Bouchillon SK, Johnson JL, Zhanel GG, Butler DL, Miller LA, Poupard JA; Gemifloxacin Surveillance Study Research Group. Comparative in vitro activity of gemifloxacin, ciprofloxacin, levofloxacin and ofloxacin in a North American surveillance study. Diagn Microbiol Infect Dis. 2001 May-Jun;40(1-2):51-7. doi: 10.1016/s0732-8893(01)00241-3.