Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

Epistaxis Clinical Trial

Official title:

Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02963129
• Other study ID #: 2666
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 9, 2016
• Last updated: November 9, 2016
• Start date: June 2017
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Hospital Italiano de Buenos Aires
• Contact: Marcelo MS Serra, MD
• Phone: 49590200
• Email: marcelo.serra[@]hospitalitalino.org.ar
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

Compare the frequency of epistaxis and quality of life related to nasal bleeding in patients with HHT colonized with sataphylococo before and after being treated with mupirocin ointment.

Description:

Hereditary hemorrhagic telangiectasia is a vascular dysplasia characterized by the development of mucocutaneous telangiectasia and arteriovenous malformations in organs such as brain, lung, liver and tube digestivo. Is considered a rare disease, although It means that there is a substantial underdiagnosis. The overall prevalence is 1/5000.

Approximately 60% of the general population hosts strains of Staphylococcus aureus (S. aureus) intermittently and are called intermittent carriers, 20% represent persistent carriers harboring the same strain of S. aureus and 20% of the population are never carriers.

On this concept, one might think that HHT patients in whom there is an active and pathological vascular remodeling that causes bleeding, and inflammation is a known activator of abnormal angiogenesis; reducing an inflammatory factor as microbial through the eradication of nasal S. aureus could be useful to reduce bleeding in this population, directly impacting on quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years with possible or confirmed HHT as diagnostic criteria Curaçao.

• Patients with nasal S. aureus colonization culture positive

Exclusion Criteria:

• Refusal to participate in the study or the informed consent process.

• Hypersensitivity or contraindication for topical mupirocin.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis
• Hereditary Hemorrhagic Telangiectasia
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Drug:
• Mupirocin
Mupirocin ointment in the nose for 5 days

Other:
• Placebo
Placebo ointment in the nose for 5 days

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires, Gascon 450	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires, Peron 4190	Ciudad Autonoma de Buenos Aires	Capital Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nosebleed by sadick scale		60 days	No
Secondary	Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive		60 days	No