跳至主要内容
临床试验/NCT03360877
NCT03360877已完成不适用

Assessing the Risk of Hospital-acquired Infection and Multi-drug Resistance Among Hospitalized Severe Acutely Malnourished Children

Epicentre0 个研究点目标入组 4,944 人开始时间: 2016年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Epicentre
入组人数
4,944
主要终点
Evaluation of the reduction of the incidence of nosocomial bacteremia

研究概览

简要总结

While the standardization of treatment protocols for Severe Acute Malnutrition (SAM) has helped to reduce historically high mortality, mortality in inpatient settings remains substantial, likely due to the severity of complications associated with late presentation and health-care associated infection (HCAI).

The purpose of this study is to serve as an important stand-alone description to inform the understanding of the magnitude of the problem and help guide implementation of measures to reduce the risk of nosocomial infection and multi-drug resistance.

详细描述

This study is designed as a cross-sectional, non-randomized, two-site, four-phase study: an initial baseline period, two intervention periods, and a final interruption period.

This is a descriptive study to collect information on the risk of HCAIs in the MSF-supported inpatient nutritional treatment centers. Information on key clinical indicators will be collected regularly according to the routine program procedures from the time of admission to discharge. All children will undergo a blood draw for culture at time of admission and at the time of any suspected hospital-acquired bloodstream infection. As part of active surveillance for bacterial colonization, including multi-drug resistant organisms, all children will undergo nasal and rectal swabs at the time of admission, suspected infection, and discharge. Data will provide an estimate of nosocomial infection incidence under routine circumstances and inform sample size calculations if further study is warranted.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 6 to 59 months old
  • severe acute malnutrition with medical complications
  • parent / caregiver signing written informed consent

排除标准

  • health condition that does not allow blood draw
  • contraindication to the use of soap or Chlorhexidine gluconate, as recommended by the product
  • refusal to discontinue the use of skin care products that are incompatible with Chlorhexidine gluconate according to the product's directions for use

结局指标

主要结局

Evaluation of the reduction of the incidence of nosocomial bacteremia

时间窗: Between 48 hours after hospitalization and less than 28 days after hospital release

To determine whether, when accompanied by the caregiver, children with severe acute malnutrition (SAM), daily cleaning with wipes containing 2% chlorhexidine gluconate (HCG) reduces the incidence of nosocomial bacteremia suspected and / or confirmed by the laboratory compared to baseline data and compared to daily soap and water cleanup administered by the caregiver.

次要结局

未报告次要终点

研究者

发起方
Epicentre
申办方类型
Other
责任方
Sponsor

相似试验