Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

Phase 3

• Conditions: Hereditary Hemorrhagic Telangiectasia; Epistaxis
• Interventions: Other: Placebo; Drug: Mupirocin

• Registration Number: NCT02963129
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-08-09
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Study First Posted: 2016-11-15
• Last Update Posted: 2016-11-15
• Study Start: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients over 18 years with possible or confirmed HHT as diagnostic criteria Curaçao.
• Patients with nasal S. aureus colonization culture positive

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Exclusion Criteria

• Refusal to participate in the study or the informed consent process.
• Hypersensitivity or contraindication for topical mupirocin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	topical placebo nasal ointment and nasal solid petroleum jelly for 5 consecutive days and then just nasal solid petroleum jelly to complete the 60 total days
Mupirocina	Mupirocin	topical mupirocin nasal ointment and nasal solid petroleum jelly for 5 consecutive days and then just nasal solid petroleum jelly to complete the 60 total days

Primary Outcome Measures

Name	Time	Method
Nosebleed by sadick scale	60 days

Secondary Outcome Measures

Name	Time	Method
Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive	60 days

Trial Locations

Locations (2)

Hospital Italiano de Buenos Aires, Gascon 450; 🇦🇷 Buenos Aires, Argentina

Hospital Italiano de Buenos Aires, Peron 4190; 🇦🇷 Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina