NCT04261348Unknown不适用
Effects of an Antimicrobial Stewardship (AMS) Program, on the Prevalence of Multidrug-resistant Gram - Negative Pathogens, in an Area of High Consumption of Antibiotics and High Resistance Rates
Laikο General Hospital, Athens1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hospital mortality rate
研究概览
简要总结
- To evaluate the long-term effect of the AMS program on the consumption of broad-spectrum antibiotics and on the consumption of antibiotics in general (sustainability of the efficacy of the program). More specifically, the investigators shall examine the consumption of protected antibiotics during the years 2019 - 2020 and they shall compare it with the consumption of antibiotics before the implementation of the AMS program.
- To evaluate the impact of the AMS program, combined with an infection control program, on the incidence of MDRGN infections in a hospital with high MDR incidence. Confounding factors are a barrier to analyze the impact of ASPs on antibiotic resistance. In a hospital setting, one of the most important confounding factors is the implementation of infection control practices at the same time as the ASPs. It is extremely difficult to infer causality between an ASP and antibiotic resistance reduction when infection control is a confounding factor, especially if the study intervention combines an ASP and infection control practices performed at the same time. The way to go around the problem is to implement ASP and IC at different time points. The investigators implemented the ASP program in September 2015 and they added the IC program in September 2018. Therefore, the investigators shall be able to compare the two-time periods (i.e. ASP alone vs. ASP/IC) by using the time series analysis and delineate the impact of each intervention.
- To evaluate the effect of the AMS program on patient outcomes (in-hospital mortality, length of stay)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hospital mortality rate
时间窗: 2 years
in-hospital mortality rate (%)
Consumption of antibiotics
时间窗: 2 years
consumption of antimicrobials (defined daily doses / 100 patient-days)
Length of stay
时间窗: 2 years
length of stay (number of days)
Days of antibiotics
时间窗: 2 yars
days of antibiotics (number of days)
Days of therapy
时间窗: 2 years
days of therapy for each drug (number of days)
Patients receiving surgical prophylaxis
时间窗: 2 years
percentage of patients receiving appropriate surgical prophylaxis
Clinical cure rate
时间窗: 2 years
clinical cure rate of the initial antibiotic regimen (%)
次要结局
未报告次要终点
研究者
Nikolaos Sipsas
Professor
Laikο General Hospital, Athens
研究点 (1)
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