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临床试验/NCT02948335
NCT02948335已完成不适用

Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital

St. Jude Children's Research Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Change in diversity index of environment microbial composition

研究概览

简要总结

Microorganisms that colonize hospital environments play an important role in the transmission of hospital acquired infections (HAI) and multi-drug resistant organisms. Previous studies examining microorganisms in the hospital environment have been limited by reliance on targeted culture-based methods resulting in potentially missed or unrecognized organisms. Evidence now suggests that using microbiome analysis offers an innovative strategy that may improve our understanding of HAI and how best to prevent them.

This pilot longitudinal observational study aims to characterize the taxonomic composition of microbial communities on environmental surfaces and people in these environments prior to and following the introduction of patients, caregiver, and hospital staff to newly constructed inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This proposed study is uniquely characterized by evaluating the hospital environment of a pediatric immunocompromised oncology patient population that has not been studied in the past using advanced molecular techniques such as microbiome analysis.

PRIMARY OBJECTIVE:

  • To describe the pattern of microbial communities of the hospital environment before, during and after patient occupancy of a newly constructed hospital space.

SECONDARY OBJECTIVES:

  • To describe the similarity or difference of environment microbial communities to that of the humans occupying this environment in a newly occupied hospital space.
  • To describe the pattern in environment microbial communities after each step of disinfection (manual cleaning with chemical disinfectant and Ultraviolet light disinfection machine) after patient discharge from the inpatient hospital environment.
  • To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures and organism bioburden.

详细描述

Participants will be recruited from the patient population at SJCRH. Patients admitted to one of the protocol defined inpatient rooms in the Kay Research and Care Center (KRCC) will be enrolled on the study. Participating patients will be asked to provide stool, nasal swab, and skin swab samples while inpatient. Primary caregivers and the nurse assigned to the patient's room will also be asked to provide nasal and skin swabs while the patient remains inpatient. These samples will be used to characterize the human microbiome for comparison to the environmental microbiome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients scheduled to be admitted or admitted to SJCRH,
  • Admitted to one of the protocol defined inpatient rooms in the KRCC building at SJCRH,
  • Patient, parents or legal guardian willing and able to provide informed consent and comply with study requirements,
  • When applicable, participant is willing to provide assent and comply with the study requirements.
  • Patient Participant

排除标准

  • Inability or unwillingness of participant or legal guardian/representative to give written informed consent.
  • Primary Caregiver Participant Inclusion Criteria
  • Primary caregiver anticipated to provide care for patient while he or she is inpatient at St. Jude Children's Research Hospital,
  • ≥ 18 years old,
  • Able and willing to provide informed consent and comply with study requirements.
  • Primary Caregiver Participant Exclusion Criteria
  • Inability or unwillingness of primary caregiver to give informed consent.
  • Primary Nurse Participant Inclusion Criteria
  • Nurse assigned to patient participant on the day of patient participant sample collection
  • Willing to provide informed consent
  • Primary Nurse Participant Exclusion Criteria
  • Inability or unwillingness to provide informed consent

结局指标

主要结局

Change in diversity index of environment microbial composition

时间窗: Before participant admission to after participant discharge, which is up to 30 days

Microbial flora colonizing a newly built hospital environment will be compared prior to participant inpatient admission to after inpatient hospital discharge. Microbiome diversity is a measure of the richness of microbial species present in the environmental sample. It is reported as diversity index.

Change in microbiome composition within the environment microbial composition

时间窗: Before participant admission to after participant discharge, which is up to 30 days

Microbial flora colonizing a newly built hospital environment will be compared prior to participant inpatient admission to after inpatient hospital discharge. Microbiome composition describes which bacteria are detected in a sample. It is reported as percentage of relative abundance of each taxa of bacteria.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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