Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

Hospital Italiano de Buenos Aires

Status and phase: Unknown; Phase 3

Conditions: Hereditary Hemorrhagic Telangiectasia; Epistaxis

Treatments: Other: Placebo; Drug: Mupirocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02963129

2666

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Mupirocina

Experimental group

Description:

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

Treatment:

Drug: Mupirocin

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo