Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

November 9, 2016 updated by: Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Italiano de Buenos Aires, Gascon 450
    • Capital Federal
      • Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires, Peron 4190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Mupirocin
Mupirocin ointment in the nose for 5 days
Other Names:
  • Mupirocina 2% ointment
Placebo Comparator: 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
Other: Placebo
Placebo ointment in the nose for 5 days
Other Names:
  • ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nosebleed by sadick scale
Time Frame: 60 days
60 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Marcelo MS Serra, MD, Staff of the Department of Clinical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2017

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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