RhinoscleromaEarly Phase 1NCT03326050
Comparison Between Rifampicin and Gemifloxacin and Ciprofloxacin in Treatment of Rhinoscleroma
A Early Phase 1 study testing Gemifloxacin, Ciprofloxacin and Rifampicin in people with Rhinoscleroma, run by Assiut University at 1 site in Egypt.
Trial summary
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Rhinoscleroma
- What is being tested?
- Gemifloxacin, Ciprofloxacin and Rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2018to Oct 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age above 18 years
- Active rhinoscleroma proved both clinically and histopathologically
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma
Read the 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)
- Conditions
- Rhinoscleroma
- Being tested
- Gemifloxacin, Ciprofloxacin, Rifampicin
- Keywords
- Rhinoscleroma, Gemifloxacin, Ciprofloxacin
- Medical subject headings
- Rhinoscleroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemifloxacinDrug
Also called Gemifloxacin 320Mg Oral Tablet
Gemifloxacin 320Mg Oral Tablet once daily
CiprofloxacinDrug
Also called Cipro 750Mg Tablet
cipro 750 tablet twice daily
RifampicinDrug
Also called Rifampicin 150Mg Capsule
Rifampicin 150Mg Capsule twice daily
| Study group | Role | What they receive |
|---|---|---|
| gemifloxacin and Rifampicin | Placebo comparator | 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.. Receives: Drug: Gemifloxacin; Drug: Ciprofloxacin; Drug: Rifampicin |
| gemifloxacin and ciprofloxacin | Placebo comparator | . 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 Receives: Drug: Gemifloxacin; Drug: Ciprofloxacin; Drug: Rifampicin |
| gemifloxacin and placipo | Placebo comparator | .group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily Receives: Drug: Gemifloxacin; Drug: Ciprofloxacin; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical examination., nasal crustation,
nasal crusting, O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)
Measured: monthly evaluation for 6 months
clinical examination purulent secretions
purulent secretions (O= no symptoms, 1 = present monthly 2= present weekly, 3 = present daily, 4 = always present, and 5 = incapacitating). (6)
Measured: monthly evaluation for 6 months
• Full ENT history
purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction
Measured: monthly evaluation for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startFeb 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for RhinoscleromaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa ahmed bekheit, Assiut University
- Investigators
- Ahmed mohamed, lecturer, Study director, assiut yunveristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326050
- Sponsor's protocol ID
- rhinoscleroma
- Status last verified
- Feb 2018
- First submitted
- 18 Oct 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26339415The Editors. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-396. doi: 10.1099/0022-1317-49-5-395. No abstract available.
PubMed 10798549Zhong 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.
PubMed 21453653Fawaz 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.
PubMed 21410904Bailhache A, Dehesdin D, Francois A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41.
PubMed 19146007Borgstein 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.
PubMed 8100894Gamea 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.
PubMed 2246576Toppozada 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.
PubMed 3734600Pound 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.
PubMed 17192170Saravolatz 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.
PubMed 14557966Hoban 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.
PubMed 11448564
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemifloxacin Versus Ciprofloxacin Versus Rifampicin in Treatment of Rhinoscleroma
- ClinicalTrials.gov ID
- NCT03326050
- Acronym / sponsor ID
- rhinoscleroma
- Conditions
- Rhinoscleroma
- Keywords
- Rhinoscleroma, Gemifloxacin, Ciprofloxacin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gemifloxacin and Rifampicin | Placebo comparator | Drug: Gemifloxacin, Drug: Ciprofloxacin, Drug: Rifampicinfirst 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 | Placebo comparator | Drug: Gemifloxacin, Drug: Ciprofloxacin, Drug: 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 | Placebo comparator | Drug: Gemifloxacin, Drug: Ciprofloxacin, Drug: Rifampicin.group will be given a short course (four weeks) of oral Gemifloxacin 320 mg once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age above 18 years
- Active rhinoscleroma proved both clinically and histopathologically
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemifloxacinAlso: Gemifloxacin 320Mg Oral TabletGemifloxacin 320Mg Oral Tablet once daily | Drug | gemifloxacin and Rifampicin, gemifloxacin and ciprofloxacin, gemifloxacin and placipo |
| CiprofloxacinAlso: Cipro 750Mg Tabletcipro 750 tablet twice daily | Drug | gemifloxacin and Rifampicin, gemifloxacin and ciprofloxacin, gemifloxacin and placipo |
| RifampicinAlso: Rifampicin 150Mg CapsuleRifampicin 150Mg Capsule twice daily | Drug | gemifloxacin and Rifampicin, gemifloxacin and ciprofloxacin, gemifloxacin and placipo |
Primary outcome
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)
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)
• Full ENT history
Time frame: monthly evaluation for 6 months
purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Results publication: PubMed 26339415Ahmed 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.
- Results publication: PubMed 10798549The Editors. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-396. doi: 10.1099/0022-1317-49-5-395. No abstract available.
- Results publication: PubMed 21453653Zhong 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.
- Results publication: PubMed 21410904Fawaz 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.
- Results publication: PubMed 19146007Bailhache A, Dehesdin D, Francois A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41.
- Results publication: PubMed 8100894Borgstein 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.
- Results publication: PubMed 2246576Gamea 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.
- Results publication: PubMed 3734600Toppozada 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.
- Results publication: PubMed 17192170Pound 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.
- Results publication: PubMed 14557966Saravolatz 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.
- Results publication: PubMed 11448564Hoban 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed mohamed, lecturer study director
assiut yunveristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gemifloxacin, Ciprofloxacin and Rifampicin in people with Rhinoscleroma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact asmaa ahmed, resident (01022091284, asmaabakhiet1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical examination., nasal crustation, (time frame: monthly evaluation for 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03326050, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.