Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

Rhinoscleroma Clinical Trial

Official title:

Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03326050
• Other study ID #: rhinoscleroma
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: October 18, 2017
• Last updated: February 12, 2018
• Start date: February 2018
• Est. completion date: October 2018

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: asmaa ahmed, resident
• Phone: 01022091284
• Email: asmaabakhiet1992[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinoscleroma

Intervention

Drug:
• Gemifloxacin
Gemifloxacin 320Mg Oral Tablet once daily
• Ciprofloxacin
cipro 750 tablet twice daily
• Rifampicin
Rifampicin 150Mg Capsule twice daily

Locations

Country	Name	City	State
Egypt	Asmaa Ahmed	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

Bailhache A, Dehesdin D, François A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41. Review. — View Citation

Borgstein J, Sada E, Cortes R. Ciprofloxacin for rhinoscleroma and ozena. Lancet. 1993 Jul 10;342(8863):122. — View 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. — View 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. — View Citation

Hart CA, Rao SK. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-6. — View 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 stu — View Citation

Pound MW, Fulton KB, Chima CO. Successful treatment of Klebsiella rhinoscleromatis bacteremia with levofloxacin. Pharmacotherapy. 2007 Jan;27(1):161-3. — View 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. Epub 2003 Oct 2. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical examination., nasal crustation,	nasal crusting, O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)	monthly evaluation for 6 months
Primary	clinical examination purulent secretions	purulent secretions (O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)	monthly evaluation for 6 months
Primary	• Full ENT history	purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction	monthly evaluation for 6 months