Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: Rhinoscleroma

Treatments: Drug: Rifampicin; Drug: Ciprofloxacin; Drug: Gemifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT03326050

rhinoscleroma

Details and patient eligibility

About

gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

Full 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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

gemifloxacin and Rifampicin

Placebo Comparator group

Description:

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..

Treatment:

Drug: Gemifloxacin

Drug: Ciprofloxacin

Drug: Rifampicin

gemifloxacin and ciprofloxacin

Placebo Comparator group

Description:

. 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

Treatment:

Drug: Gemifloxacin

Drug: Ciprofloxacin

Drug: Rifampicin

gemifloxacin and placipo

Placebo Comparator group

Description:

.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily

Treatment:

Drug: Gemifloxacin

Drug: Ciprofloxacin

Drug: Rifampicin