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

NCT ID: NCT01400308

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-12-31

Brief Summary

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

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).

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection; MRSA Colonization

Keywords

Methicillin Resistant Staphylococcus Aureus colonization.; Methicillin Resistant Staphylococcus Aureus infection.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Mupirocin + Chlorhexidin

Intervention Type: DRUG

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)

Prontoderm

Will be treated with the protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.

Group Type: EXPERIMENTAL

Prontoderm MRSA Kit

Intervention Type: DEVICE

Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.

Prontoderm® is a Class III medical device

Interventions

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)

Intervention Type: DRUG

Prontoderm MRSA Kit

Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.

Prontoderm® is a Class III medical device

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Medical SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafael Ortí, Dr.

Role: PRINCIPAL_INVESTIGATOR

Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia

Locations

Hospital General Universitario de Elche.

Elche, Valencia, Spain

Hospital Clínic Universitari de Valencia.

Valencia, Valencia, Spain

Hospital Arnau de Vilanova

Valencia, Valencia, Spain

Hospital Universitari de Bellvitge

Barcelona, , Spain

Countries

Spain

Other Identifiers

OPM-G-H-0903

Identifier Type: -

Identifier Source: org_study_id