Clinical trial NCT01400308: Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by Methicillin Resistant Staphylococcus Aureus (MRSA)
Official title: Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
MRSA Colonization
Keywords: Methicillin Resistant Staphylococcus Aureus colonization.
Methicillin Resistant Staphylococcus Aureus infection.
Lead sponsor: B. Braun Medical SA
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Decolonization of MRSA patients
timeFrame: Final treatment day + 4 (by second control sample)
Secondary outcomes:
measure: Percent of decolonization out of total by trained staff treated patients
timeFrame: Up to two years
measure: Quantitative (0-10 scale) and qualitative (open questions) measure of the usability of experimental and control products by users
timeFrame: The fifth, final day of treatment
measure: Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by staff
timeFrame: The fifth, final day of treatment
measure: Quantitative (0-10 scale) and qualitative (open questions) measure of the organoleptic features of experimental and control products by patients
timeFrame: The fifth, final day of treatment
measure: Quantitative (0-10 scale) and qualitative (open questions) measure of the acceptance of experimental and control products by patient
timeFrame: The fifth, final day of treatment
measure: Percent of decolonization in with Prontoderm® treated multiresistant colonizations decolonization for other multiresistant organisms (not MRSA)
timeFrame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
measure: Incidence and prevalence of multidrug resistant bacteria after experimental vs control treatment
timeFrame: After completation of treatment (5 days) two culture are done (2nd day and forth day after finishing) and colonizationd + resistances are mesured
measure: Delta (decrease or increase) in MRSA epidemiology (incidence, prevalence) for the centre comparing the years before trial and after trial
timeFrame: Up to two years
measure: Assess the efficiency (economic impact) of the proposed protocol
timeFrame: Up to two years
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche.
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Valencia
country: Spain
facility: Hospital Clínic Universitari de Valencia.
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Responsible for Preventive Medicine Hospital Clínic Universitari de Valencia
name: Rafael Ortí, Dr.
role: PRINCIPAL_INVESTIGATOR
References: