Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Decolonization
研究概览
简要总结
Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial.
The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction.
Secondary objectives are:
- To evaluate the safety of FMT.
- To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT.
- To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention.
- To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention.
- To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> = 18 years.
- •Signature of the informed consent by the patient or legally designated person
- •Absence of active infection by carbapenemase-type KPC-producing Klebsiella pneumoniae at the time of assessment as well as in the month prior to inclusion in the study
排除标准
- •Terminal situation, or estimated life expectancy of less than 3 months
- •Pregnant or lactating women
- •Intolerance or inability to take oral medication at the time of assessment
- •History of aspiration or dysphagia
- •Patients with a history of colectomy, colostomy or ileostomy
- •Patients who are receiving or have received antibiotics in the month prior to the inclusion assessment
- •Neutrophil count less than 500 cells / mm3
- •Anticipation of the use of myelosuppressive treatment (eg. dexamethasone, chemotherapy against to solid tumors or prior to transplantation of hematopoietic progenitories) within 30 days after inclusion in the study
- •Hematopoietic stem cell transplantation in the month prior to inclusion in the study
- •Presence of clinical signs of mucositis
- •Forecast of major abdominal surgical intervention in the month following inclusion in the study
- •Patients with a Gianella Score> 12 points
- •History of having received decolonization guidelines in the previous 3 months
- •Severe food allergy
结局指标
主要结局
Decolonization
时间窗: 30 days after treatment.
Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.
次要结局
- Percentage of patients with adverse effects(90 days after treatment.)
- Bacterial load(7 days and 30 days after treatment.)
- Mortality(90 days after treatment.)
- Persistent intestinal decolonization(90 days after treatment.)
- Infections caused by Kp-KPC(90 days after treatment.)