- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326050
Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma
Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: asmaa ahmed, resident
- Phone Number: 01022091284
- Email: asmaabakhiet1992@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Asmaa Ahmed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age above 18 years
- Active rhinoscleroma proved both clinically and histopathologically
Exclusion Criteria:
- Patients younger than 18 years old.
- inactive Rhinoscleroma
- Contraindication to treatment severe renal or hepatic impairment
- Refusal of enrollment in the research by the patient
Study Plan
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..
|
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
cipro 750 tablet twice daily
Other Names:
Rifampicin 150Mg Capsule twice daily
Other Names:
|
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
|
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
cipro 750 tablet twice daily
Other Names:
Rifampicin 150Mg Capsule twice daily
Other Names:
|
Placebo Comparator: gemifloxacin and placipo
.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily
|
Gemifloxacin 320Mg Oral Tablet once daily
Other Names:
cipro 750 tablet twice daily
Other Names:
Rifampicin 150Mg Capsule twice daily
Other Names:
|
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
Sponsor
Investigators
- Study Director: Ahmed mohamed, lecturer, assiut yunveristy
Publications and helpful links
General Publications
- 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.
- The Editors. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-396. doi: 10.1099/0022-1317-49-5-395. No abstract available.
- 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.
- 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.
- Bailhache A, Dehesdin D, Francois A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41.
- Borgstein J, Sada E, Cortes R. Ciprofloxacin for rhinoscleroma and ozena. Lancet. 1993 Jul 10;342(8863):122. doi: 10.1016/0140-6736(93)91329-k. No abstract available.
- Gamea AM, el-Tatawi FA. The effect of rifampicin on rhinoscleroma: an electron microscopic study. J Laryngol Otol. 1990 Oct;104(10):772-7. doi: 10.1017/s002221510011388x.
- Toppozada HH, Gaafar HA. The effect of streptomycin and irradiation on rhinoscleroma (electron microscopic study). J Laryngol Otol. 1986 Jul;100(7):809-15. doi: 10.1017/s0022215100100118.
- Pound MW, Fulton KB, Chima CO. Successful treatment of Klebsiella rhinoscleromatis bacteremia with levofloxacin. Pharmacotherapy. 2007 Jan;27(1):161-3. doi: 10.1592/phco.27.1.161.
- Saravolatz LD, Leggett J. Gatifloxacin, gemifloxacin, and moxifloxacin: the role of 3 newer fluoroquinolones. Clin Infect Dis. 2003 Nov 1;37(9):1210-5. doi: 10.1086/378809. Epub 2003 Oct 2.
- 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 study. Diagn Microbiol Infect Dis. 2001 May-Jun;40(1-2):51-7. doi: 10.1016/s0732-8893(01)00241-3.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Nose Diseases
- Skin Diseases, Bacterial
- Enterobacteriaceae Infections
- Klebsiella Infections
- Rhinoscleroma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Cytochrome P-450 CYP1A2 Inhibitors
- Rifampin
- Ciprofloxacin
- Gemifloxacin
Other Study ID Numbers
- rhinoscleroma
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rhinoscleroma
-
Assiut UniversityNot yet recruiting
-
CSA Medical, Inc.TerminatedLung Diseases, Obstructive | Wegener's Granulomatosis | Sarcoidosis | Recurrent Respiratory Papillomatosis | RhinoscleromaUnited States
Clinical Trials on Gemifloxacin
-
Samsung Medical CenterUnknownHelicobacter Pylori InfectionKorea, Republic of
-
Shaheed Benazir Bhutto University Sheringal Dir...Khyber Medical University PeshawarCompletedHypoglycemia | Blood Glucose, LowPakistan
-
LG Life SciencesCompleted
-
Tanta UniversityRecruitingSpontaneous Bacterial PeritonitisEgypt
-
National Institute of Allergy and Infectious Diseases...Completed