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Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326050
Recruitment Status : Unknown
Verified February 2018 by asmaa ahmed bekheit, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 30, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
asmaa ahmed bekheit, Assiut University

Brief Summary:
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

Condition or disease Intervention/treatment Phase
Rhinoscleroma Drug: Gemifloxacin Drug: Ciprofloxacin Drug: Rifampicin Early Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : October 2018


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 Name: Gemifloxacin 320Mg Oral Tablet

Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Name: Cipro 750Mg Tablet

Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Name: 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 Name: Gemifloxacin 320Mg Oral Tablet

Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Name: Cipro 750Mg Tablet

Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Name: 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 Name: Gemifloxacin 320Mg Oral Tablet

Drug: Ciprofloxacin
cipro 750 tablet twice daily
Other Name: Cipro 750Mg Tablet

Drug: Rifampicin
Rifampicin 150Mg Capsule twice daily
Other Name: Rifampicin 150Mg Capsule




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. • Full ENT history [ Time Frame: monthly evaluation for 6 months ]
    purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326050


Contacts
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Contact: asmaa ahmed, resident 01022091284 asmaabakhiet1992@gmail.com

Locations
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Egypt
Asmaa Ahmed
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Ahmed mohamed, lecturer assiut yunveristy
Publications of Results:

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Responsible Party: asmaa ahmed bekheit, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03326050    
Other Study ID Numbers: rhinoscleroma
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by asmaa ahmed bekheit, Assiut University:
Rhinoscleroma
Gemifloxacin
Ciprofloxacin
Additional relevant MeSH terms:
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Rhinoscleroma
Klebsiella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Skin Diseases
Ciprofloxacin
Rifampin
Gemifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers