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临床试验/NCT02963129
NCT02963129Unknown3 期

Treatment of Nasal Staphylococcus Aureus Colonization in Patients With Hereditary Hemorrhagic Telangiectasia With Recurrent Epistaxis.

Hospital Italiano de Buenos Aires2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
40
试验地点
2
主要终点
Nosebleed by sadick scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years with possible or confirmed HHT as diagnostic criteria Curaçao.
  • Patients with nasal S. aureus colonization culture positive

排除标准

  • Refusal to participate in the study or the informed consent process.
  • Hypersensitivity or contraindication for topical mupirocin.

研究组 & 干预措施

Mupirocina

Experimental

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

干预措施: Mupirocin (Drug)

Control

Placebo Comparator

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

干预措施: Placebo (Other)

结局指标

主要结局

Nosebleed by sadick scale

时间窗: 60 days

次要结局

  • Prevalence of nasal colonization with Staphylococcus in patients with HHT by nasal cultive(60 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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