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

NCT01400308 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2013-08-02

No results posted yet for this study

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

Interventions

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)

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

Sponsors & Collaborators

  • B. Braun Medical SA

    lead INDUSTRY

Principal Investigators

  • Rafael Ortí, Dr. · Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400308 on ClinicalTrials.gov