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

NCT01400308 | Terminated Phase 4

• 1 other identifier: OPM-G-H-0903
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 4

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.

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection; MRSA Colonization

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (2)

Chlorhexidine + Mupirocin

ACTIVE COMPARATOR

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

Prontoderm

EXPERIMENTAL

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

Device: Prontoderm MRSA Kit

Interventions

Mupirocin + Chlorhexidin 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)

Chlorhexidine + Mupirocin

Prontoderm MRSA Kit DEVICE

Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics. Prontoderm® is a Class III medical device

Prontoderm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- MRSA infected or colonized Patients

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Medical SA: lead

Study Sites (4)

Hospital General Universitario de Elche.

Elche, Valencia, 03203, Spain

Location

Hospital Clínic Universitari de Valencia.

Valencia, Valencia, 46010, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

MeSH Terms

Interventions

Mupirocin; Chlorhexidine

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines

Study Officials

• Rafael Ortí, Dr.

  Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 22, 2011
• Study Start: February 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

ES (4)