Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Simple analysis and logistic regression (to adjust for risk factors, sources, concomitant therapy, etc) compared the frequency of decolonization of MRSA, according to sources. Procedures: To collect information using a standardized form CRD in paper to all hospitals, indicating the parameters listed in this protocol and cultures to be done both baseline and monitoring cultures DISEASE IN STUDY This will be treated either or both of the following conditions: MRSA Colonization: The presence of the organism in the flora of the patient, detected by positive culture for MRSA, and no diagnosis of infection. MRSA infections: presence of the organism between the flora of the patient, detected by positive culture for MRSA, and the presence of MRSA infection diagnosed according to criteria EPINE 2009 (Annex 8).

Official Title
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Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)

Conditions
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MRSA - Methicillin Resistant Staphylococcus Aureus Infection, MRSA Colonization

Intervention / Treatment
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* Drug: Mupirocin + Chlorhexidin
* Device: Prontoderm MRSA Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - MRSA infected or colonized Patients Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine + Mupirocin<br>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). | Drug: Mupirocin + Chlorhexidin<br>* Treatment after protocol described in the Consensus document and GEIH-SEIMC SEMPSPH Version 31/10/07. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days)<br>|
| Experimental: Prontoderm<br>Will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. | Device: Prontoderm MRSA Kit<br>* Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Prontoderm® is a Class III medical device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decolonization of MRSA patients | 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. | Final treatment day + 4 (by second control sample) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of decolonization out of total by trained staff treated patients | For both arms, determine the importance of staff training and the proper procedure in the application of hygiene measures, by comparing trial outcomes with same centre historical outcomes regarding MRSA decolonization | Up to two years | 
| Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users | Measure of user satisfaction regarding the usability of the experimental product vs control, by self-administered questionnaire. The fifth and final day of treatment the staff fills out a questionnaire that includes questions about product usability | 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 | Measure of user satisfaction regarding features of the experimental product vs control, by self-administered questionnaire. The fifth and final day of treatment the staff fills out a questionnaire that includes questions about products' features | 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 | Measure of patient rating satisfaction regarding the organoleptic features of the experimental product vs control, by self-administered questionnaire.The fifth and final day of treatment the staff fills out a questionnaire that includes questions about product organoleptic features | 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 | Measure of patients' satisfaction regarding features of the experimental product vs control product, by self-administered questionnaire. The fifth and final day of treatment the patient fills out a questionnaire that includes questions about product acceptance | The fifth, final day of treatment | 
| Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA) | Rate effectiveness of Prontoderm® for other multiresistant organisms (such as Acinetobacter, Pseudomonas, Vancomycin Resistant Enterococcus , E. Coli, Klebsiella and other Enterobacteriaceae producing ESBL). In the pretreatment culture not only MRSA but also other of the above mentioned bacteria can appear. After finishing treatment, the decolonization of these other bacteria will be assessed (effectiveness of product) | 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 | To assess the difference in the appearance of multidrug resistance between both arms | 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 | Mesure of impact of the experimental protocol on the epidemiology by measuring the decrease or increase in MRSA epidemiology (incidence, prevalence) after applying the experimental protocol compared with historical figures from the center- in hospitals where there is a vigilance system for nosocomial infection | Up to two years | 
| Assess the efficiency (economic impact) of the proposed protocol | Costs of both (experimental and control) treatments will be compared, considering not only price of products, but other MRSA treatment related resources such as staff time, isolation days, etc, to assess the efficiency, economic impact, of the proposed protocol with Prontoderm®, compared with control treatment. | Up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methicillin Resistant Staphylococcus Aureus colonization., Methicillin Resistant Staphylococcus Aureus infection.