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临床试验/NCT02401204
NCT02401204已完成不适用

Bacterial Transmission Surveillance in Neonatal Intensive Care Unit: Transmission Dynamics and Drug Resistance Patterns

University of Oxford1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2015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
97
试验地点
1
主要终点
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.

研究概览

简要总结

Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of infections with these pathogens represent asymptomatic carriage, though in the absence of routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of transmission between patients, and rates of importation from the community are lacking. Moreover, current understanding of the degree and manner in which different antibiotics act to select for such resistant organisms is rudimentary.

详细描述

Objectives: To quantify the prevalence of drug-resistant Gram-negative pathogens on admission to a neonatal intensive care unit and during subsequent days of hospital stay. To quantify rates of patient-to-patient transmission for key organisms, to characterize how patient antibiotic use impacts on the ward-level dynamics of such organisms.

Methods: All infants admitted to the unit over a period of one year for whom the parent/guardian gives informed consent will be included. In addition to routine demographic and clinical data for included patients, full patient-level data on antibiotic use within the ward will also be recorded. Carriage of resistant Gram-negative organisms will be determined though rectal swabs, tracheal aspirates (for ventilated patients) and stool samples taken on admission and at twice weekly intervals. Antibiotic-resistant Gram-negative bacteria will be cultured and their resistant patterns determined. Selected environmental surfaces will also be sampled to detect contamination with such organisms. For the most important organisms (Acinetobacter spp. and Klebsiella spp.) whole genome sequencing will be used in conjunction with Bayesian data augmentation techniques to determine transmission pathways and the impact of antibiotic use on the transmission and persistence of such organisms within the hospital ward.

研究设计

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

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • All neonates admitted to QSNICH NICU
  • Parent/legal guardian gives written informed consent

排除标准

  • There are no exclusion criteria for this study

结局指标

主要结局

Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.

时间窗: During admission in NICU unit

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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