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
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Hemorrhagic Telangiectasia Epistaxis||Drug: Mupirocin Other: Placebo||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
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
Placebo ointment in the nose for 5 days
Other Name: ointment
- Nosebleed by sadick scale [ Time Frame: 60 days ]
- Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive [ Time Frame: 60 days ]
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
|Contact: Marcelo MS Serra, MD||49590200 ext firstname.lastname@example.org|
|Contact: Cristina CE Elizondo, MD||49590200 ext email@example.com|
|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|
|Principal Investigator:||Marcelo MS Serra, MD||Staff of the Department of Clinical Medicine|