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

This study has been terminated.
(The differences seen between treatments led to recalculation of the sample, unattainable in a reasonable time)
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical SA
ClinicalTrials.gov Identifier:
NCT01400308
First received: July 19, 2011
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
MRSA Colonization
Drug: Mupirocin + Chlorhexidin
Device: Prontoderm MRSA Kit
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)

Resource links provided by NLM:


Further study details as provided by B. Braun Medical SA:

Primary Outcome Measures:
  • Decolonization of MRSA patients [ Time Frame: Final treatment day + 4 (by second control sample) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent of decolonization out of total by trained staff treated patients [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    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

  • Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users [ Time Frame: The fifth, final day of treatment ] [ Designated as safety issue: No ]
    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

  • Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff [ Time Frame: The fifth, final day of treatment ] [ Designated as safety issue: No ]
    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

  • Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients [ Time Frame: The fifth, final day of treatment ] [ Designated as safety issue: No ]
    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

  • Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient [ Time Frame: The fifth, final day of treatment ] [ Designated as safety issue: No ]
    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

  • Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA) [ Time Frame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured ] [ Designated as safety issue: No ]

    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)


  • Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment [ Time Frame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured ] [ Designated as safety issue: No ]
    To assess the difference in the appearance of multidrug resistance between both arms

  • Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    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

  • Assess the efficiency (economic impact) of the proposed protocol [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: February 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400308

Locations
Spain
Hospital General Universitario de Elche.
Elche, Valencia, Spain, 03203
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Hospital Arnau de Vilanova
Valencia, Spain, 46015
Hospital Clínic Universitari de Valencia.
Valencia, Spain, 46010
Sponsors and Collaborators
B. Braun Medical SA
Investigators
Principal Investigator: Rafael Ortí, Dr. Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia
  More Information

No publications provided

Responsible Party: B. Braun Medical SA
ClinicalTrials.gov Identifier: NCT01400308     History of Changes
Other Study ID Numbers: OPM-G-H-0903
Study First Received: July 19, 2011
Last Updated: August 1, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by B. Braun Medical SA:
Methicillin Resistant Staphylococcus Aureus colonization.
Methicillin Resistant Staphylococcus Aureus infection.

Additional relevant MeSH terms:
Infection
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Chlorhexidine
Methicillin
Mupirocin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014