Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

February 12, 2018 updated by: asmaa ahmed bekheit, Assiut University

Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma

gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Asmaa Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: gemifloxacin and 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..
Drug: Gemifloxacin
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
  • Gemifloxacin 320Mg Oral Tablet
Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Names:
  • Cipro 750Mg Tablet
Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Names:
  • Rifampicin 150Mg Capsule
Placebo Comparator: gemifloxacin and 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
Drug: Gemifloxacin
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
  • Gemifloxacin 320Mg Oral Tablet
Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Names:
  • Cipro 750Mg Tablet
Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Names:
  • Rifampicin 150Mg Capsule
Placebo Comparator: gemifloxacin and placipo
.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
Drug: Gemifloxacin
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
  • Gemifloxacin 320Mg Oral Tablet
Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Names:
  • Cipro 750Mg Tablet
Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Names:
  • Rifampicin 150Mg Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical examination., nasal crustation,
Time Frame: 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)
monthly evaluation for 6 months
clinical examination purulent secretions
Time Frame: 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)
monthly evaluation for 6 months
• Full ENT history
Time Frame: monthly evaluation for 6 months
purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction
monthly evaluation for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed mohamed, lecturer, assiut yunveristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rhinoscleroma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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