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Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

Primary Purpose

Hereditary Hemorrhagic Telangiectasia, Epistaxis

Status
Unknown status
Phase
Phase 3
Locations
Argentina
Study Type
Interventional
Intervention
Mupirocin
Placebo
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hereditary Hemorrhagic Telangiectasia focused on measuring Hereditary Hemorrhagic Telangiectasia, Epistaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Hospital Italiano de Buenos Aires, Peron 4190
  • Hospital Italiano de Buenos Aires, Gascon 450

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mupirocina

Control

Arm 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

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

Outcomes

Primary Outcome Measures

Nosebleed by sadick scale

Secondary Outcome Measures

Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive

Full Information

First Posted
August 9, 2016
Last Updated
November 9, 2016
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT02963129
Brief Title
Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT
Official Title
Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Hemorrhagic Telangiectasia, Epistaxis
Keywords
Hereditary Hemorrhagic Telangiectasia, Epistaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mupirocina
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Mupirocin
Other Intervention Name(s)
Mupirocina 2% ointment
Intervention Description
Mupirocin ointment in the nose for 5 days
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
ointment
Intervention Description
Placebo ointment in the nose for 5 days
Primary Outcome Measure Information:
Title
Nosebleed by sadick scale
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo MS Serra, MD
Phone
49590200
Ext
4806
Email
marcelo.serra@hospitalitalino.org.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina CE Elizondo, MD
Phone
49590200
Ext
4806
Email
cristina.elizondo@hospitalitalino.org.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo MS Serra, MD
Organizational Affiliation
Staff of the Department of Clinical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires, Peron 4190
City
Ciudad Autonoma de Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1199ABB
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires, Gascon 450
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

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