Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Decolonization of MRSA patients
研究概览
简要总结
Multicenter Clinical Trial, experimental, randomized and prospective study to determine the effectiveness of two protocols addressing the Corporal Decolonization in patients colonized by Methicillin Resistant Staphylococcus Aureus (MRSA).
PRIMARY END POINT The aim of this trial is to evaluate the effectiveness of the protocol Prontoderm® in the decolonization of MRSA patients, compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" (see attached extract from the document, Annex 7).
Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain for the same indications proposed in this trial.
详细描述
Design: Multicenter, experimental, randomized and prospective study. The patients were consecutively and alternately assigned to each comparison group. Randomization was assured by central randomization and the first patient to one of the groups and, from there, too centrally, back to each of the two groups.
Group A will be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days).
Group B will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Ensure the correct application of the treatments without interruption over the weekend indicated protocol.
Sample Calculation: The investigators propose an initial sample of 310 patients for a bilateral approach with a type I error α = 0.05 and β type II error of 20%.
Analysis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •MRSA infected or colonized Patients
排除标准
- •Patients whose condition or treatment interferes with the proper implementation of the proposed protocols, such as:
- •Patients admitted to the ICU
- •Patients undergoing resuscitation
- •Immobilized patients-avoiding their complete hygiene
- •Patients carrying nasogastric tube
- •Patients with tracheostomy and / or assisted mechanical ventilation
- •Patients who are unable, neither they nor their representatives, to give valid informed consent.
- •Patients whose discharged is planned before completing protocol
研究组 & 干预措施
Chlorhexidine + Mupirocin
Will be treated with the protocol described in the "Consensus document and GEIH-SEIMC SEMPSPH" Version 31/10/07, as shown listed in Table 4. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days).
干预措施: Mupirocin + Chlorhexidin (Drug)
Prontoderm
Will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.
干预措施: Prontoderm MRSA Kit (Device)
结局指标
主要结局
Decolonization of MRSA patients
时间窗: Final treatment day + 4 (by second control sample)
The aim of this trial is to evaluate the effectiveness of the protocol "Prontoderm ® in the decolonization of MRSA patients", compared with the protocol of the "Consensus Document and GEIH-SEIMC SEMPSPH" Prontoderm ® is a Class III Medical Device with CE mark owned by B.BRAUN Medical SA, and currently available in Spain and all over Europe for the same indications proposed in this trial.
次要结局
- Percent of decolonization out of total by trained staff treated patients(Up to two years)
- Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users(The fifth, final day of treatment)
- Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff(The fifth, final day of treatment)
- Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients(The fifth, final day of treatment)
- Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient(The fifth, final day of treatment)
- Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA)(After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured)
- Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment(After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured)
- Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial(Up to two years)
- Assess the efficiency (economic impact) of the proposed protocol(Up to two years)