2025-523453-34-00招募中3 期
Targeted versus standard peri-operative prophylaxis in patients colonized with carbapenemase-producing Enterobacterales undergoing liver transplantation: a stepped-wedge cluster randomization trial
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico3 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2026年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 3
- 主要终点
- The treatment effect of T-PAP over S-PAP is intended as a reduced CPE infection rate in the first two weeks after LT in the intervention with respect to the control group.
研究概览
简要总结
To investigate the impact of T-PAP vs. S-PAP on the incidence of early CPE infection after LT in patients colonized with CPE undergoing LT
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 4
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years) patients colonized with CPE undergoing liver transplantation (LT)
- •Informed consent signed by the enrolled patients
排除标准
- •Active infection from any Gram-negative bacteria at the time of LT
- •High risk of donor-derived CPE infection (e.g., donors known to be colonized or infected with CPE at the time of death, or CPE isolated from donor blood or preservation fluid samples)
- •Hypersensitivity to the active substance or to any of the excipients
- •Pregnancy and breastfeeding
- •Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.
- •History of severe immediate hypersensitivity reactions (e.g., anaphylaxis) to beta-lactam agents (e.g., cephalosporins, carbapenems, or monobactams).
- •Colonization by strains resistant to all Investigational Medicinal Products (IMPs)
结局指标
主要结局
The treatment effect of T-PAP over S-PAP is intended as a reduced CPE infection rate in the first two weeks after LT in the intervention with respect to the control group.
The treatment effect of T-PAP over S-PAP is intended as a reduced CPE infection rate in the first two weeks after LT in the intervention with respect to the control group.
次要结局
- The dynamics of gut microbiome will be assessed evaluating differences in diversity, composition at different taxonomic levels and functionality between and within groups over time, at the time of LT, and at 14, 30, 60 and 90 days after LT.
- The occurrence of any CPE and non-CPE infection within 14 days from LT in relation to optimal PK/PD attainment in patients colonized with CPE will be assessed as described in paragraph 3.3 for the primary endpoint.
- CPE carriage status, development of any type of bacterial infections and all-cause mortality, will be assessed at 30, 60 and 90 days from the date of LT both singularly and as a composite defined as: no events (discharged and decolonized); discharged and not decolonized; discharged and infected; still hospitalized or readmitted with infection; died.
- Endpoint for safety is an adverse event potentially related to the study drugs (e.g. neurotoxicity, nephrotoxicity, immediate and delayed hypersensitivity manifestations) occurring during prophylaxis administration or within 7 days from the initiation of administration (delayed hypersensitivity reactions).
研究者
Maddalena Giannella
Scientific
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
研究点 (3)
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