Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01400308
Study type Interventional
Source B. Braun Medical SA
Contact
Status Terminated
Phase Phase 4
Start date February 2010
Completion date December 2011

See also
  Status Clinical Trial Phase
Completed NCT00448942 - The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections N/A
Recruiting NCT04104178 - Optimal Treatment of MRSA Throat Carriers Phase 3
Terminated NCT00929435 - Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Carriage Rates in Resident Physicians N/A
Completed NCT04347057 - The Effect of Chlorhexidine Bathing on MRSA and VRE Colonization Among Haematology-Oncology ICU Patients N/A
Completed NCT01820455 - MRSA in a Trauma Population: Does Decolonization Prevent Infection? N/A
Withdrawn NCT00941356 - Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients Phase 2
Completed NCT01234831 - A Novel Approach to Methicillin-resistant Staphylococcus Aureus (MRSA) Screening of Colonized Patients N/A
Completed NCT00151606 - Comparison of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus. N/A
Recruiting NCT00502476 - Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections N/A