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

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

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.

Study Overview

• Status: Terminated
• Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection; MRSA Colonization
• Intervention / Treatment: Drug: Mupirocin + Chlorhexidin; Device: Prontoderm MRSA Kit

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
  • Valencia, Spain, 46010
    • Hospital Clínic Universitari de Valencia.
  • Valencia
    • Elche, Valencia, Spain, 03203
      • Hospital General Universitario de Elche.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Mupirocin + Chlorhexidin; 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)
Experimental: Prontoderm; Will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.	Device: Prontoderm MRSA Kit; Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Prontoderm® is a Class III medical device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: B. Braun Medical SA
• Investigators: Principal Investigator: Rafael Ortí, Dr., Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Methicillin Resistant Staphylococcus Aureus colonization.; Methicillin Resistant Staphylococcus Aureus infection.
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Mupirocin
• Other Study ID Numbers: OPM-G-H-0903