NCT00631566已完成不适用
Prospective Study on the Incidence, Predictors, and Characteristics of Methicillin-Resistant Staphylococcus Aureus Infections and a Randomized, Double-Blind Study on Decolonization Procedures for Prevention of MRSA Infections Among HIV-Infected Persons
Henry M. Jackson Foundation for the Advancement of Military Medicine4 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 4
- 主要终点
- The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
研究概览
简要总结
This study will prospectively evaluate the prevalence and incidence (over a two year period) of MRSA colonization and infection among HIV-infected military beneficiaries to determine predictors for the development of MRSA colonization and infection. This study will also investigate the utility of decolonization procedures for clearance of MRSA carriage and prevention of MRSA infections. Finally, the molecular characteristics and the antimicrobial sensitivities of isolates in this population will be determined.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (at least 18 years of age) who are HIV positive by a reactive screening (ELISA, EIA) and a confirmatory test (Western blot) and who are able to attend the study visits which are every 6 months (+/- 2 months), at the minimum
排除标准
- •Known allergy to mupirocin (Bactroban®) nasal ointment or hexachlorophene (pHisoHex®) soaps or constituents of these products.
- •Age less than 18 years.
- •Inability to remain in the study for the two year duration.
- •Pregnant or breastfeeding females.
- •Females who intend to become pregnant during the two year study time period.
- •Persons who are healthcare providers with direct patient contact.
研究组 & 干预措施
1
Experimental
干预措施: Mupirocin (Bactroban) 2%; hexachlorophene (pHisoHex) 3% (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Presence of MRSA on Repeated Swabs to Assess the Efficacy of These Medications on Clearing MRSA Colonization
时间窗: 6 months
MRSA colonization at 6-months post-randomization
次要结局
- To Determine the Prevalence and Incidence of MRSA Colonization of the Nares, Throat, Perirectal, Axilla, and Groin Areas Among HIV Infected Patients and to Study Changes in the Colonization Rates Over Time.(Every 6 months)
- To Evaluate the Change in CD4 Counts and HIV Viral Loads During the Time of a MRSA or Soft Tissue Infection.(At time of infection)
- To Characterize the Molecular Characteristics and the Antimicrobial Sensitivities of MRSA Isolates in This Population.(at time of positive MRSA results)
研究者
研究点 (4)
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