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临床试验/NCT02572791
NCT02572791已完成4 期

Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 835 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
835
试验地点
2
主要终点
Number of Households With at Least One Skin and Soft Tissue Infection

研究概览

简要总结

The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces. The central hypothesis of this proposal is that an integrated approach of periodic personal and household environmental hygiene will reduce S. aureus transmission in households and subsequently decrease the incidence of skin and soft tissue infections (SSTI).

详细描述

Patients with active or recent S. aureus SSTI will be recruited from St. Louis Children's Hospital and community pediatric practices affiliated with the investigators practice-based research network. All participants (index patients and their household contacts) will perform a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization regimen, households will be randomized to one of three intervention groups: 1) Periodic personal decolonization performed by all household members, to include chlorhexidine body washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated periodic personal decolonization and household environmental hygiene for 3 months. Households will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the prevalence of S. aureus colonization in the participants, household environmental surfaces, and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain typing will be performed on all recovered S. aureus isolates to illuminate transmission dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the investigators will assess resistance to the prescribed topical antimicrobials at baseline and longitudinal samplings.

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
None

入排标准

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

入选标准

  • Patients 18 years of age and younger
  • Confirmed (i.e., culture-positive) active or recent (within the past 2 months) S. aureus cutaneous infections
  • Reside within 75 miles of St. Louis Children's Hospital
  • Provide written, informed consent, or consent is provided by a parent or legal guardian

排除标准

  • Patients with nosocomial infections (i.e., >48 hours after hospitalization)
  • Patients with traditional risk factors for HA-MRSA (e.g., immunodeficiency, indwelling catheter or percutaneous medical device, undergoing dialysis, presenting with a surgical site infection, or residing in a long-term care facility within the past year).
  • Patients who are unable to give consent or for whom consent is not obtained
  • Patients refusing home environmental cultures by the study team
  • Patients without a permanent home (e.g., living in a shelter or group home)

研究组 & 干预措施

Periodic personal decolonization

Experimental

All household participants will perform chlorhexidine body washes twice weekly for 3 months and apply mupirocin ointment to the anterior nares twice daily for five consecutive days each month for 3 months.

干预措施: Chlorhexidine (Drug)

Periodic personal decolonization

Experimental

All household participants will perform chlorhexidine body washes twice weekly for 3 months and apply mupirocin ointment to the anterior nares twice daily for five consecutive days each month for 3 months.

干预措施: Mupirocin (Drug)

Household environmental hygiene

Experimental

In addition to their usual cleaning, households will be asked to perform targeted household hygiene focusing on sources known to harbor S. aureus and serve as reservoirs for transmission.

干预措施: Household cleaning (Behavioral)

Integrated personal/household hygiene

Experimental

Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2.

干预措施: Chlorhexidine (Drug)

Integrated personal/household hygiene

Experimental

Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2.

干预措施: Mupirocin (Drug)

Integrated personal/household hygiene

Experimental

Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2.

干预措施: Household cleaning (Behavioral)

结局指标

主要结局

Number of Households With at Least One Skin and Soft Tissue Infection

时间窗: 3 months after randomization

Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups.

次要结局

  • SSTI Incidence: Index Patients(9 Months)
  • Prevalence of MRSA Colonization in Participants(Baseline sampling)
  • Prevalence of MRSA Colonization in Participants(9 months)
  • Confirmed S. Aureus Infection(9 months)
  • Incidence of SSTI(1 month)
  • Incidence of SSTI(6 months)
  • Incidence of SSTI(9 months)
  • Mupirocin Resistance(9 months)
  • Number of Patients With Adverse Events Due to Study Intervention(3 months)
  • Number of Participants Adhering to Study Intervention Procedures(3 months)
  • SSTI Incidence: Individual Level(1 Month)
  • SSTI Incidence: Individual Level(3 Months)
  • SSTI Incidence: Individual Level(6 Months)
  • SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment(1 Month)
  • SSTI Incidence: Index Patients(6 Months)
  • SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment(3 Months)
  • SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment(6 Months)
  • SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment(9 Months)
  • SSTI Incidence: Index Patients(1 Month)
  • SSTI Incidence: Index Patients(3 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie A. Fritz

Professor of Pediatrics

Washington University School of Medicine

研究点 (2)

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