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
About this trial
This is an interventional treatment trial for Hereditary Hemorrhagic Telangiectasia focused on measuring Hereditary Hemorrhagic Telangiectasia, Epistaxis
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.
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
NCT ID
NCT02963129
First Posted
August 9, 2016
Last Updated
November 9, 2016
Sponsor
Hospital Italiano de Buenos Aires
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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