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Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

NCT ID: NCT02963129

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2017-12-31

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.

Conditions

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Hereditary Hemorrhagic Telangiectasia Epistaxis

Keywords

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Hereditary Hemorrhagic Telangiectasia Epistaxis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mupirocina

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

Group Type EXPERIMENTAL

Mupirocin

Intervention Type DRUG

Mupirocin ointment in the nose for 5 days

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo ointment in the nose for 5 days

Interventions

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Mupirocin

Mupirocin ointment in the nose for 5 days

Intervention Type DRUG

Placebo

Placebo ointment in the nose for 5 days

Intervention Type OTHER

Other Intervention Names

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Mupirocina 2% ointment ointment

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcelo MS Serra, MD

Role: PRINCIPAL_INVESTIGATOR

Staff of the Department of Clinical Medicine

Locations

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Hospital Italiano de Buenos Aires, Peron 4190

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Hospital Italiano de Buenos Aires, Gascon 450

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Central Contacts

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Marcelo MS Serra, MD

Role: CONTACT

Phone: 49590200

Email: [email protected]

Cristina CE Elizondo, MD

Role: CONTACT

Phone: 49590200

Email: [email protected]

Other Identifiers

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2666

Identifier Type: -

Identifier Source: org_study_id