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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Frequency of subjects with MRSA decolonization
研究概览
简要总结
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®.
详细描述
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Patients withdrawn from the study retain their patient number if already given.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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Frequency of subjects with MRSA decolonization
时间窗: 21 days
次要结局
- To evaluate the secondary effects (incidence rate of non-serious ans serious adverse events)associated to the administration of the study product(21 days)