NCT01293071已完成4 期
The SATURN Consortium, "Impact of Specific Antibiotic Therapies on the Prevalence of hUman Host ResistaNt Bacteria". Workpackage 2: The SATURN ICU-trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens
研究概览
简要总结
The SATURN ICU-trial studies the effect of antibiotic rotation on the prevalence of antibiotic resistant Gram-negative colonisation.
详细描述
Antibiotic rotation has been previously studied with varied results. The theory behind antibiotic rotation is that intermittently changing antibiotic classes will reduce the ecological selective pressure that drives the emergence of antibiotic resistance.
This study compares the effect of 2 types of antibiotic rotation on Gram-negative colonisation in the ICU and also compares both interventions with standard care.
The two interventions apply to the empiric treatment and are: 1) "fast" rotation, i.e. every other patient another class and 2) "slow" rotation, i.e. every other 1.5month another preferred class for empiric Gram-negative antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •There are at least 8 beds, with an average bed-occupancy of 80%; all of which have capacity for mechanical ventilation.
- •The ICU can adhere to the selected antibiotics for empiric treatment of infections.
- •There is an operational digital patient-information system, from which data can be extracted and delivered in a pre-defined format. Specifically an automated process for digital data-collection regarding microbiological culture-results (from swabs and bacteraemias), antibiotic prescription and patient demographics and illness severity-scores.
- •Colonization with ESBL or resistance for any of the antibiotic groups is endemic, with proportions of ICU-acquired bacteraemias used as a proxy. Therefore, the investigators prefer proportions of AMRB infection in the period 2008-2009 to be: ESBL resistance among GNB 1 to 10% Piperacillin/Tazobactam among GNB 1 to10% Carbapenem resistance among Klebsiella Pneumoniae less than 5%
- •Have the ability of at least one dedicated Infection Control HCW available for 0,2fte, for patient monitoring, compliance monitoring and instruction of HCWs regarding interventions. In the following this person will be called "Research-Nurse" or "RN".
- •Can store screening-cultures at -70ºC
- •Can facilitate transport through a UMCU courier.
- •There is written approval for the study from the institution's IRB with a waiver for patient informed consent.
- •A signature page is signed by the daily management of the candidate-ICU by both ICU physician and director and the ICU nursing-director and presented to the UMCU, indicating willingness to enroll the candidate-ICU in the study.
排除标准
- •ICUs planning to introduce, during the SATURN trial period, any major diagnostic- or intervention program that will affect AMRB ecology*
- •Burn units; due to the specific nature of the care provided and the patients admitted.
- •Cardiothoracic surgery units; because of the expected small number of patients admitted for three days or more.
- •Paediatric and neonatal ICUs.
结局指标
主要结局
Mean prevalence of ICU patients colonised with antimicrobial resistant Gram-negative pathogens
时间窗: Monthly point-prevalence screening of all ICU patients
次要结局
- AMRB acquisition incidence, measured as status conversion from noncolonized to colonized during admission at ICU per 100 patients.(2011-2013)
- ICU-acquired bacteraemia rate with AMRB (expressed as the rate of ICU-acquired bacteraemia per 1000 patient-days)(2011-2013)
- Overall length of ICU-stay hospital-stay and percentage of in-hospital mortality of the total admitted ICU-population.(2011-2013)
- Effectiveness of empirical treatment of ICU-acquired bacteraemia, expressed as proportion of bacteraemia for which appropriate antibiotics are administered within 24 hours with antibiotics that the specific pathogens is susceptible for.(2011-2013)
研究者
研究点 (2)
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