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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02963129
Other study ID # 2666
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received August 9, 2016
Last updated November 9, 2016
Start date June 2017
Est. completion date December 2017

Study information

Verified date November 2016
Source Hospital Italiano de Buenos Aires
Contact Marcelo MS Serra, MD
Phone 49590200
Email marcelo.serra@hospitalitalino.org.ar
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years with possible or confirmed HHT as diagnostic criteria CuraƧao.

- 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Mupirocin
Mupirocin ointment in the nose for 5 days
Other:
Placebo
Placebo ointment in the nose for 5 days

Locations

Country Name City State
Argentina Hospital Italiano de Buenos Aires, Gascon 450 Buenos Aires
Argentina Hospital Italiano de Buenos Aires, Peron 4190 Ciudad Autonoma de Buenos Aires Capital Federal

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nosebleed by sadick scale 60 days No
Secondary Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive 60 days No
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