NCT06057194尚未招募2 期
Prospective Study to Assess the Efficacy of Letermovir Prophylaxis in Preventing CMV Infection in Lung Transplant Recipients Compared to a Retrospective Cohort Treated With Standard Valganciclovir Prophylaxis for 12 Months (LETERCOR Study)
Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of CMV disease/replication
研究概览
简要总结
The goal of this quasi-experimental multicenter before-after cohort study, phase II study is to evaluate the efficacy of 12-month letermovir prophylaxis in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who received 12 months of valganciclovir prophylaxis to prevent CMV disease."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Letermovir (prospective cohort)
Experimental
2 tablets of 240 milligrams (mg) Letermovir orally once daily. during 12 months
干预措施: Letermovir 240 mg Oral Tablet (Drug)
结局指标
主要结局
Incidence of CMV disease/replication
时间窗: During 12 months after initiation of prophylaxis
CMV replication: The term 'replication' can be used to indicate evidence of multiplication and is sometimes used interchangeably with CMV infection CMV disease: It is defined as symptomatic replication or invasive disease of organs or tissues that requires treatment at the investigator's discretion."
次要结局
- Duration of treatment of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)(During 12 months after initiation of prophylaxis)
- Substitution of letermovir by intravenous ganciclovir or foscarnet IV, related to CMV antiviral toxicity(During 12 months after initiation of prophylaxis)
- Incidence of leucopenia(During 12 months after initiation of prophylaxis)
- Dose of non anti-viral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)(During 12 months after initiation of prophylaxis)
- Incidence of neutropenia(During 12 months after initiation of prophylaxis)
- Antiviral prophylaxis received:(During 12 months after initiation of prophylaxis)
- Discontinuation of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)(During 12 months after initiation of prophylaxis)
- Reduction of the antiviral dose related to CMV antiviral toxicity(During 12 months after initiation of prophylaxis)
- Use of granulocyte colony-stimulating factors (G-CSF).(During 12 months after initiation of prophylaxis)
- Hospital readmission associated with CMV complication(During 12 months after initiation of prophylaxis)
- Administration route of non-antiviral CMV Medications: Any non-antiviral therapy received as standard of care (SoC) for the management of CMV (e.g., immunoglobulins)(During 12 months after initiation of prophylaxis)
- Dose changes of immunosuppressive therapy related to CMV antiviral toxicity(During 12 months after initiation of prophylaxis)
- Incidence of viral, bacterial, or opportunistic fungal infections during the study follow-up period.(During 12 months after initiation of prophylaxis)
- Changes of immunosuppressive therapy related to CMV antiviral toxicity(During 12 months after initiation of prophylaxis)
- Incidence of renal toxicity directly related to CMV antivirals.(During 12 months after initiation of prophylaxis)
研究者
研究点 (1)
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