RGNOSIS: Ecological Effects of Decolonisation Strategies in Intensive Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8,665
- 试验地点
- 13
- 主要终点
- ICU-Ecology
研究概览
简要总结
Previous research has shown that applying certain treatments can reduce both the number of infections and the presence of resistant bacteria in the intensive care (ICU) and its patients. These treatments have been used as standard care throughout the world for many years, but they have not been compared to each other yet. The investigators aim to evaluate the effect of 3 different treatments on the occurrence of resistant bacteria and bacterial infections in the ICU and to establish which treatment is the best.
All adult patients undergoing mechanical ventilation are eligible for this study and will receive treatment according to the study scheme. Twice weekly, sputum and rectal samples will be obtained to measure the effects.
All ICU-patients will receive standard treatment, consisting of daily body washing with an antiseptic (chlorhexidine 2%), oral care and a hand-hygiene program for health care workers as endorsed by the WHO. According to 4 different study periods, each participant will receive one of the following extra treatments depending on his or her admission date:
- Standard treatment only (this is the control group)
- Chlorhexidine 1% oral gel, this is an antiseptic.
- Antibiotic mouth paste containing 3 different antibiotics (selective oropharyngeal decontamination, SOD).
- Antibiotic mouth paste and suspension for the stomach and intestines containing 3 different antibiotics (selective digestive decontamination, SDD).
All treatments will be given 4 times daily with the purpose of killing harmful bacteria in the mouth (CHX, SOD,SDD) and digestive tract (SDD).
During the study the investigators will examine the effect of these treatments on:
- the occurrence of blood stream infections with certain bacteria
- cross-transmission of certain bacteria between patients
- presence of these bacteria in the respiratory tract of the patients
- patient survival
Benefits: Previous research has shown that these interventions can reduce infections in intensive care patients.
Risks: The interventions performed (both cultures and treatment) are considered safe and are already given as standard care in many ICUs throughout the world. There is a slight risk that bacteria become resistant to antibiotics: this will be monitored closely during the trial.
详细描述
Introduction
The "R-GNOSIS: Ecological Effects of Decolonization Strategies in Intensive Care" study assesses three decolonization interventions against standard care to evaluate unit wide ecological effects and compare effectiveness.
Previous studies have demonstrated that decontamination interventions were beneficial to individual patients but also influence ICU ecology, affecting patients who do not receive the intervention. Decolonization with antibiotics have been shown to reduce the prevalence of resistant bacteria during treatment [de Smet et al. NEJM 2009]. Reducing the presence of these bacteria in some patients (that are decolonized), reduces cross transmission and is therefore beneficial to all patients in the unit. The decolonization strategies therefore represent an intensive care unit population rather than an individual patient intervention. In this respect the study represents a cluster-cluster randomized clinical trial which requires the intervention is undertaken on the whole ICU population [Edwards et al. BMJ 1999].
As decolonization strategies represent an ecological intervention on the whole critical care population, all patients meeting inclusion/exclusion criteria will be entered into the study according to ethics approval in each participating country. Each participating ICU will use three decolonization strategies in a randomised order. The interventions are administered four times daily to ventilated patients until extubation. The interventions will be compared to a 6 month baseline period consisting of standard care only.
Standard operating procedures
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mechanical ventilation (only invasive ventilation: i.e. intubated patients or patients with tracheostomal ventilation)
- •no planned extubation within 24 hours When mechanical ventilation is not started directly after admission but later in the course of their ICU stay, patients are still eligible to participate.
排除标准
- •patients under the age of 18
- •patients with known allergy to any of the medications or agents used (i.e. colistin, tobramycin, nystatin or chlorhexidine )
- •pregnancy
- •Participation ends as soon as the patient is extubated or after tracheostomal ventilation has stopped (weaning completed).
研究组 & 干预措施
Standard care
Standard infection prevention measurements will be implemented before the baseline period and carried out throughout the entire trial. They consist of:
- Chlorhexidine 2% body washings (CHX-BW) for all ICU patients. The face and neck of the patient will not be cleansed with Chlorhexidine to prevent irritation of the eyes and face.
- A hand hygiene improvement program (HHIP) based on the program designed by the World Health organisation (WHO).
- Standard oropharyngeal care consists of oral washing with sterile water (3-4 times daily) and tooth brush twice daily.
干预措施: Chlorhexidine oral care (CHX-Oro) (Drug)
Standard care
Standard infection prevention measurements will be implemented before the baseline period and carried out throughout the entire trial. They consist of:
- Chlorhexidine 2% body washings (CHX-BW) for all ICU patients. The face and neck of the patient will not be cleansed with Chlorhexidine to prevent irritation of the eyes and face.
- A hand hygiene improvement program (HHIP) based on the program designed by the World Health organisation (WHO).
- Standard oropharyngeal care consists of oral washing with sterile water (3-4 times daily) and tooth brush twice daily.
干预措施: Selective oropharyngeal decontamination (SOD) (Drug)
Standard care
Standard infection prevention measurements will be implemented before the baseline period and carried out throughout the entire trial. They consist of:
- Chlorhexidine 2% body washings (CHX-BW) for all ICU patients. The face and neck of the patient will not be cleansed with Chlorhexidine to prevent irritation of the eyes and face.
- A hand hygiene improvement program (HHIP) based on the program designed by the World Health organisation (WHO).
- Standard oropharyngeal care consists of oral washing with sterile water (3-4 times daily) and tooth brush twice daily.
干预措施: Selective Digestive Decontamination (SDD) (Drug)
Chlorhexidine oral care (CHX-Oro)
Chlorhexidine digluconate oromucosal gel 1%, 2cm, to be administered 4 times daily, during invasive mechanical ventilation.
干预措施: Chlorhexidine oral care (CHX-Oro) (Drug)
Selective oropharyngeal decontamination
Selective oropharyngeal decontamination (SOD) mouth paste containing colistin and tobramycin in a 2% concentration and nystatin 1 x 10^5 units, dosage 0.5g , to be administered 4 times daily during the entire period of invasive mechanical ventilation.
干预措施: Selective oropharyngeal decontamination (SOD) (Drug)
Selective digestive decontamination
Selective digestive decontamination (SDD), suspension via the nasogastric tube containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10^6 i.u., dosage 10ml, to be administered together with SOD (see above) 4 times daily during entire period of mechanical ventilation.
干预措施: Selective Digestive Decontamination (SDD) (Drug)
结局指标
主要结局
ICU-Ecology
时间窗: 27 months
To determine the ecological effects of decolonisation regimens (SDD, SOD and CHX-Oro) in reducing (MDR-GNB) ICU-acquired bacteraemia when compared to standard care.
次要结局
- ward-level systemic antibiotic use(27 months)
- colonization in relation to bacteraemia(27 months)
- Patient survival(27 months)
- transmission capacities of different bacteria(27 months)
- Respiratory tract colonization(27 months)
- Cross-transmission rates(27 months)
- bacteraemia with resistant bacteria(27 months)
研究者
MJM Bonten
Professor of Molecular Epidemiology of Infectious Diseases
UMC Utrecht