2023-504384-16-00招募中2 期
Prospective study to evaluate the efficacy of letermovir prophylaxis for the prevention of CMV infection in lung transplant recipients compared to a retrospective cohort treated with standard valganciclovir prophylaxis for 12 months (LETERCOR Study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.
研究概览
简要总结
Evaluate the efficacy of letermovir prophylaxis for 12 months in lung transplant recipients (D+/R-) compared to a historical cohort of lung transplant recipients (D+/R-) who were prescribed with a 12-month prophylaxis with valganciclovir to prevent CMV disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Lung transplant patients (D+/R-) pre-transplant
- •Have an undetectable PCR-CMV within 96 hours prior to the start of letermovir prophylaxis (prospective cohort)
- •Patients who have given their written informed consent (prospective cohort)
- •Patients prescribed (intention to treat) with valganciclovir prophylaxis for 12 months (retrospective cohort)
- •Patients transplanted between 18/05/2020 and 18/11/2022 (retrospective cohort)
排除标准
- •HIV-infected patients
- •Multivisceral transplant patients
- •Patients who cannot comply with the study protocol (prospective cohort)
- •Receiving an antiviral prophylaxis other than ganciclovir or valganciclovir prior to letermovir prophylaxis (prospective cohort)
- •Patients with simultaneous renal and hepatic insufficiency (prospective cohort)
结局指标
主要结局
Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.
Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.
次要结局
- Administered doses of Letermovir or Valganciclovir
- CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins)
- Changes in the patient's medication directly related to the toxicity of CMV antivirals
- Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL)
- Hospital readmission associated with CMV complications
- Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period
- Incidence of renal toxicity directly related to CMV antivirals
- Rate of patients achieving functional CMV-specific cell-mediated immunity (CMI-CMV) levels after receiving letermovir prophylaxis during the 6 months following discontinuation.
- Rate of CMV-seropositive patients after receiving letermovir prophylaxis during the 6 months following discontinuation
研究者
Jose Carlos Garrido Gracia
Scientific
Fundacion Para La Investigacion Biomedica De Cordoba
研究点 (7)
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