NCT03326050

Brief Summary

gemifloxacin versus ciprofloxacin and rifampicin in treatment of rhinoscleroma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

October 18, 2017

Last Update Submit

February 12, 2018

Conditions

Rhinoscleroma

Keywords

RhinoscleromaGemifloxacinCiprofloxacin

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    monthly evaluation for 6 months

  • • Full ENT history

    purulent rhinorrhea, postnasal discharge, nasal crustation, hyposmia, and nasal obstruction

    monthly evaluation for 6 months

Study Arms (3)

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..

Drug: GemifloxacinDrug: CiprofloxacinDrug: 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

Drug: GemifloxacinDrug: CiprofloxacinDrug: Rifampicin

gemifloxacin and placipo

PLACEBO COMPARATOR

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

Drug: GemifloxacinDrug: CiprofloxacinDrug: Rifampicin

Interventions

GemifloxacinDRUG

Gemifloxacin 320Mg Oral Tablet once daily

Also known as: Gemifloxacin 320Mg Oral Tablet
gemifloxacin and Rifampicingemifloxacin and ciprofloxacingemifloxacin and placipo
CiprofloxacinDRUG

cipro 750 tablet twice daily

Also known as: Cipro 750Mg Tablet
gemifloxacin and Rifampicingemifloxacin and ciprofloxacingemifloxacin and placipo
RifampicinDRUG

Rifampicin 150Mg Capsule twice daily

Also known as: Rifampicin 150Mg Capsule
gemifloxacin and Rifampicingemifloxacin and ciprofloxacingemifloxacin and placipo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age above 18 years
  • Active rhinoscleroma proved both clinically and histopathologically

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Ahmed

Asyut, Egypt

Location

Related Publications (11)

  • 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.

    PMID: 26339415RESULT

  • The Editors. Rhinoscleroma. J Med Microbiol. 2000 May;49(5):395-396. doi: 10.1099/0022-1317-49-5-395. No abstract available.

    PMID: 10798549RESULT

  • 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.

    PMID: 21453653RESULT

  • 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.

    PMID: 21410904RESULT

  • Bailhache A, Dehesdin D, Francois A, Marie JP, Choussy O. Rhinoscleroma of the sinuses. Rhinology. 2008 Dec;46(4):338-41.

    PMID: 19146007RESULT

  • 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.

    PMID: 8100894RESULT

  • 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.

    PMID: 2246576RESULT

  • 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.

    PMID: 3734600RESULT

  • 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.

    PMID: 17192170RESULT

  • 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.

    PMID: 14557966RESULT

  • 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.

    PMID: 11448564RESULT

MeSH Terms

Conditions

Rhinoscleroma

Interventions

GemifloxacinTabletsCiprofloxacinRifampin

Condition Hierarchy (Ancestors)

Klebsiella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialRespiratory Tract InfectionsSkin Diseases, InfectiousNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NaphthyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsFluoroquinolones4-QuinolonesQuinolonesQuinolinesDosage FormsPharmaceutical PreparationsRifamycinsHeterocyclic Compounds, 4 or More RingsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Ahmed mohamed, lecturer

    assiut yunveristy

    STUDY DIRECTOR

Central Study Contacts

asmaa ahmed, resident

CONTACT

01022091284asmaabakhiet1992@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 30, 2017

Study Start

February 1, 2018

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

EG(1)