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Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT

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ClinicalTrials.gov Identifier: NCT02963129
Recruitment Status : Unknown
Verified November 2016 by Hospital Italiano de Buenos Aires.
Recruitment status was:  Not yet recruiting
First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

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.

Condition or disease Intervention/treatment Phase
Hereditary Hemorrhagic Telangiectasia Epistaxis Drug: Mupirocin Other: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.
Study Start Date : June 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017


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 Name: 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 Name: ointment




Primary Outcome Measures :
  1. Nosebleed by sadick scale [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive [ Time Frame: 60 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963129


Contacts
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Contact: Marcelo MS Serra, MD 49590200 ext 4806 marcelo.serra@hospitalitalino.org.ar
Contact: Cristina CE Elizondo, MD 49590200 ext 4806 cristina.elizondo@hospitalitalino.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires, Peron 4190
Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
Hospital Italiano de Buenos Aires, Gascon 450
Buenos Aires, Argentina
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Marcelo MS Serra, MD Staff of the Department of Clinical Medicine

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Responsible Party: Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02963129     History of Changes
Other Study ID Numbers: 2666
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospital Italiano de Buenos Aires:
Hereditary Hemorrhagic Telangiectasia
Epistaxis
Additional relevant MeSH terms:
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Epistaxis
Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action