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

Condition(s) targeted: MRSA - Methicillin Resistant Staphylococcus Aureus Infection; MRSA Colonization

Intervention: Mupirocin + Chlorhexidin (Drug); Prontoderm MRSA Kit (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: B. Braun Medical SA

Official(s) and/or principal investigator(s):
Rafael Ortí, Dr., Principal Investigator, Affiliation: Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia

Overall contact:
Susana Peñuelas, Dr., Phone: +34 935902282, Email: susana.penuelas@bbraun.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Decolonization of MRSA patients

Secondary outcome:

Percent of decolonization out of total by trained staff treated patients

Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users

Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff

Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients

Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient

Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA)

Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment

Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial

Assess the efficiency (economic impact) of the proposed protocol

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Susana Peñuelas, Dr., Phone: +34 935902282, Email: susana.penuelas@bbraun.com

Hospital Universitari de Bellvitge, Barcelona 08907, Spain; Recruiting
Cristina Masuet, Dr, Phone: +34 932607557, Email: cmasuet@bellvitgehospital.cat
Josep Maria Ramon, Dr., Principal Investigator
Cristina Masuet, Dr., Sub-Investigator
Laura Gavaldà, Dr., Sub-Investigator
Carmen Micheo, Dr., Sub-Investigator

Hospital Clínic Universitari de Valencia., Valencia 46010, Spain; Recruiting
Rafael Ortí, Dr., Phone: +34 963861998, Email: orti_raf@gva.es
Rafael Ortí, Dr., Principal Investigator

Hospital Arnau de Vilanova, Valencia 46015, Spain; Recruiting
Montserrat del Bosque, Dr., Principal Investigator
Jose Luis Micó, Sub-Investigator

Hospital General Universitario de Elche., Elche, Valencia 03203, Spain; Recruiting
Juan Francisco Navarro, Dr., Principal Investigator
Mercedes Arencibia, Dr., Sub-Investigator
Isidro García, Sub-Investigator
Rafael Almela, Sub-Investigator
Gerardo Pérez, Dr., Sub-Investigator
Jaime Calle, Dr., Sub-Investigator
Pilar López, Dr., Sub-Investigator
Montserrat Ruiz, Dr., Sub-Investigator
Félix Gutiérrez, Dr., Sub-Investigator
Sergio Padilla, Dr., Sub-Investigator

Starting date: February 2010
Last updated: August 23, 2011