Evaluation of the Efficacy of Bio-K+ Cl-1285® In the Nasal Decolonization of Methicillin Resistan⦠(NCT00941356) | Clinical Trial Compass
WithdrawnPhase 2
Evaluation of the Efficacy of Bio-K+ Cl-1285Ā® In the Nasal Decolonization of Methicillin Resistant Staphylococcus Aureus (MRSA) Carrier Patients
Stopped: Unable to recruit patients to continue on with the study.
Canada0Started 2010-01
Plain-language summary
Trial Objectives:
Primary objective:
* To evaluate the efficacy of Bio-K+CL1285Ā® in patients with Methicillin-Resistant S. aureus (MRSA) nasal colonization by comparing the MRSA decolonization following either Bio-K+CL1285Ā® or placebo treatment.
Secondary objective:
* To evaluate the safety profile of Bio-K+CL1285Ā®.
Who can participate
Age range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients having ā„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 Criteria:
* 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 (catheterā¦