MRSA Colonization Clinical Trial
Official title:
Clinical Trial to Compare the Effectiveness of Two Protocols for Corporal Decolonization in Patients Colonized by MRSA (Methicillin Resistant Staphylococcus Aureus)
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.
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).
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