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临床试验/NCT01781182
NCT01781182已完成不适用

Infant Antibiotic Resistance and Implications for Therapeutic Decision-making

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
352
试验地点
1
主要终点
Colonization with resistant organism of interest

研究概览

简要总结

Escalating resistance to antibiotics among disease-causing community bacteria increasingly threatens our ability to treat patients' infections. At the level of the physician-patient encounter, incentives at the patient level often take priority to society; this is often the case with antibiotic prescribing. Each patient level antibiotic treatment decision is based on how we value potential outcomes, including short-term benefits and risks and longer-term risks, including those related to future bacterial resistance to antibiotics. Unfortunately, antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a very small likelihood of benefit seems to outweigh an increased risk of future antibiotic resistance. While short-term effects of antibiotics on colonization with resistant bacteria have been demonstrated, the overall implications of each treatment for future individual, family and societal-level resistance remain difficult to quantify, and are often steeply discounted or ignored during decision-making. Knowledge regarding the longer-term effects of personal and household antibiotic use could better quantify these future resistance-related risks, and help guide antibiotic decision-making for physicians and patients.

Infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the 1st year of life, become important reservoirs of resistant organisms; this creates an opportunity to study colonization and resistance starting from a microbiological tabula rasa. In this proposal, we will use an observational cohort to following newborns' antibiotic exposure and longitudinal colonization with specific bacterial pathogens and related antibiotic resistance in the 1st year of life. Our hypothesis is that during the 1st year of life, infants with personal and household antibiotic exposure will have greater colonization with resistan organisms than infants without antibiotic exposure. This project will help us understand the development of bacteria that are resistant to antibiotics within the community, and help to inform judicious decision-making regarding antibiotic prescribing.

研究设计

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

入排标准

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

入选标准

  • Infant in regular nursery at University Hospitals CWRU
  • Mother has legal custody
  • Mother is >=18 years old
  • Mother's and baby's physicians have granted permission for possible enrollment
  • Mother speaks, reads and understands the English language

排除标准

  • Does not fit inclusion criteria

结局指标

主要结局

Colonization with resistant organism of interest

时间窗: First 12 months of life

次要结局

未报告次要终点

研究者

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

Sharon Meropol, MD, PhD

Assistant Professor of Pediatrics and Epidemiology and Biostatistics9

University Hospitals Cleveland Medical Center

研究点 (1)

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