drugset / Trial / NCT01400308

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

NCT01400308

Phase 4 Terminated 99 enrolled B. Braun Medical SA
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorhexidine Small molecule
Comparator Mupirocin Small molecule Intranasal