Status:
WITHDRAWN
Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
Lead Sponsor:
Bio-K Plus International Inc.
Collaborating Sponsors:
Centre Hospitalier Pierre-Le Gardeur
Conditions:
MRSA Colonization
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 follo...
Detailed 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 sch...
Eligibility Criteria
Inclusion
- Male or female patients having ≥18 years of age
- Women of child bearing capacity who are not pregnant at the moment of screening (Pregnancy test done on-site) and agree to use an acceptable form of birth control for the duration of the study (e.g. condom, oral contraceptives, etc.) are allowed to participate.
- Patients must have nasal MRSA colonization confirmed with MRSA positive culture as assessed during the screening visit without any clinical signs or symptoms of infection.
- Laboratory test results within the normal ranges.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients treated for nasal MRSA decolonization in the last 6 months;
- Current infection with MRSA;
- Ongoing or active infection;
- Daily probiotic/ fermented milk or Yogurt use;
- Known to have shown a previous reaction, including anaphylaxis, to any substance in composition of the study agent (capsules);
- Ongoing or recent use of antibiotics in the 30 days prior to the study agent administration;
- Pregnancy, breastfeeding;
- Regular use of nasal agents;
- Uncontrolled intercurrent illness, including situations that would limit compliance with study requirements;
- Patients with open wounds
- Immunosuppressive therapy or any health condition causing inmunosuppression (Including Haematological malignancies, AIDS);
- Ostomized patients, parenteral nutrition users;
- Patients with current vascular access (catheter) or planned to have installed a vascular access (catheter) or any prosthesis during the study period.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00941356
Start Date
January 1 2010
End Date
July 1 2016
Last Update
July 22 2022
Active Locations (1)
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1
Pierre Le Gardeur Hospital
Terrebonne, Quebec, Canada, J6V 2H2