Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hereditary Hemorrhagic Telangiectasia, Epistaxis

Intervention / Treatment
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* Drug: Mupirocin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mupirocina<br>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 | Drug: Mupirocin<br>* Mupirocin ointment in the nose for 5 days<br>* Other names: Mupirocina 2% ointment;|
| Placebo Comparator: Control<br>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 | Other: Placebo<br>* Placebo ointment in the nose for 5 days<br>* Other names: ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nosebleed by sadick scale |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary Hemorrhagic Telangiectasia, Epistaxis