Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients — MRSA  

MRSA Colonization Clinical Trial

Official title: A Single Center, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients

Status Withdrawn

Clinical Trial Summary

Trial Objectives:

Primary objective:

• To evaluate the efficacy of Bio-K+CL1285® in patients with Methicillin-Resistant S. aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either Bio-K+CL1285® or placebo treatment.

Secondary objective:

• To evaluate the safety profile of Bio-K+CL1285®.

Clinical Trial Description

Study Design:

Double-blind, randomized (1:1 randomization), placebo-controlled, single center Canadian study.

Patients will be randomly assigned to one of the two study products. A randomization schedule will be generated by the sponsor for each participating centre. This schedule will link patient identification numbers to one of the two study products allocated at random. The schedule will be prepared on a 1:1 randomization ratio.

The study products will be labelled with the patient identification number. Patients have to be randomized in the order in which they qualify from the screening phase for inclusion in the study.

Patients withdrawn from the study retain their patient number if already given. New patients must always be allotted a new identification number (PIN).

Study Duration:

The duration of patient participation in the study will be between 22 and 23 days. The overall duration of the study is expected to be approximately 10 months; with subject recruitment proposed to start in March 2009, the last follow-up visit is expected in May 2010. The actual overall study duration or subject recruitment period may vary.

Number of Sites (inside and outside of Canada):

One center in the province of Quebec will be involved in the study. ;

Related Conditions & MeSH terms

• MRSA Colonization
• Staphylococcal Infections

• NCT number: NCT00941356
• Study type: Interventional
• Source: Bio-K Plus International Inc.
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2010
• Completion date: July 2016