- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02963129
Treatment of Nasal Staphylococcus Aureus Colonization in Patients With HHT
Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Marcelo MS Serra, MD
- Phone Number: 4806 49590200
- Email: marcelo.serra@hospitalitalino.org.ar
Study Contact Backup
- Name: Cristina CE Elizondo, MD
- Phone Number: 4806 49590200
- Email: cristina.elizondo@hospitalitalino.org.ar
Study Locations
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-
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Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires, Gascon 450
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Capital Federal
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Ciudad Autonoma de Buenos Aires, Capital Federal, Argentina, C1199ABB
- Hospital Italiano de Buenos Aires, Peron 4190
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Mupirocin ointment in the nose for 5 days
Other Names:
|
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
|
Placebo ointment in the nose for 5 days
Other Names:
|
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
Investigators
- Principal Investigator: Marcelo MS Serra, MD, Staff of the Department of Clinical Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Otorhinolaryngologic Diseases
- Hemostatic Disorders
- Signs and Symptoms, Respiratory
- Nose Diseases
- Cardiovascular Abnormalities
- Vascular Malformations
- Epistaxis
- Telangiectasis
- Telangiectasia, Hereditary Hemorrhagic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Mupirocin
Other Study ID Numbers
- 2666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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