A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment
研究概览
简要总结
MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was previously shown, that intestinal colonization with extended-spectrum β-lactamases (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et al., 2016].
To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy and safety of selective intestinal decolonization strategies in high-risk patients with haematological malignancies. Possible decolonization of MDR gram-negative bacteria in haematological patients could be important for the patient by reducing the risk of infection and for the community by reducing the risk of transmission.
The purpose of the proposed study is to assess the efficacy and safety of selective intestinal decolonization of MDR gram-negative bacteria with oral administration of Colistimethate sodium in high risk patients with haematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Microbiologically proven rectal carriage of ESBL-producing Enterobacteriaceae or carbapenem-resistant Enterobacteriaceae, A. baumannii, P. aeruginosa without signs and symptoms of active infection.
- •Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.
排除标准
- •Active bacterial, viral, fungal or protozoal infection
- •Women who are pregnant or nursing
- •Antibacterial therapy in previous 10 days
- •Contraindication to the use of one of the study drugs (including known hypersensitivity)
- •Patient already enrolled in another study, or in the present study for a previous episode
- •Psychiatric disorder or unable to understand or to follow the protocol directions
- •Resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics proven by methods of polymerase chain reaction
研究组 & 干预措施
Selective intestinal decolonization
Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days
干预措施: Colistimethate Sodium (Drug)
结局指标
主要结局
Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment
时间窗: 21 days
次要结局
- Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics(21 days)
研究者
Ihar Iskrou
Head of Cell Transplant Division
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology