Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

Early Phase 1

• Conditions: Rhinoscleroma
• Interventions: Drug: Gemifloxacin; Drug: Ciprofloxacin; Drug: Rifampicin

• Registration Number: NCT03326050
• Lead Sponsor: Assiut University

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)

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-10-30
• Status Verified: 2018-02
• Study Start: 2018-02
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13
• Primary Completion: 2018-09-01
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age above 18 years
2. Active rhinoscleroma proved both clinically and histopathologically

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemifloxacin and Rifampicin	Rifampicin	first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
gemifloxacin and Rifampicin	Gemifloxacin	first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
gemifloxacin and ciprofloxacin	Gemifloxacin	. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
gemifloxacin and Rifampicin	Ciprofloxacin	first group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once dailygroup will be given the usual regimen given for free by the Ministry of Health in Egypt; Rifampicin 300 mg twice daily for three months..
gemifloxacin and ciprofloxacin	Ciprofloxacin	. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
gemifloxacin and ciprofloxacin	Rifampicin	. group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily group will be given a short course (four weeks) of oral Ciprofloxacin 750 mg twice daily
gemifloxacin and placipo	Gemifloxacin	.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
gemifloxacin and placipo	Ciprofloxacin	.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
gemifloxacin and placipo	Rifampicin	.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asmaa Ahmed; 🇪🇬 Assiut, Egypt