2022-501429-19-00招募中3 期
CMV preemptive therapy in high-risk immunocompetent major heart surgery patients. A multicenter, double blind, randomized, clinical trial (GAN-CAR).
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon, Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon5 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2023年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 226
- 试验地点
- 5
- 主要终点
- Number of days of good outcome during the 30 days follow-up. A good outcome implies that the patient is alive, out of the ICU, with no systemic antimicrobials, no mechanical ventilation, and no SAEs.
研究概览
简要总结
To determine the clinical impact of administering targeted pre-emptive antiviral therapy to high-risk (≥3 days in the cardiac surgery ICU and CMV viral load), immunocompetent adults, after MHS.
研究设计
- 分配方式
- Randomized
- 主要目的
- Epoch 2.
- 盲法
- Double (Subject, Monitor, Investigator)
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
- 是
入选标准
- •Written informed consent must be obtained before any study-specific assessment is performed.
- •Adult patients (≥18 years old).
- •Patients that underwent a MHS in the last 90 days prior to inclusion.
- •Patients remaining in the ICU at least 72h after the surgery.
- •Female patients of child-bearing potential must have a negative urine pregnancy test at screening and agree to use reliable methods of contraception upon enrolment according to the recommendations provided by CTFG, during the treatment period and for one month following the last dose of investigational drug.
- •Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrolment according to the recommendations provided by CTFG, during the treatment period, and for 3 months following the last dose of investigational drug.
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
排除标准
- •Immunocompromised patients: HIV positive infection, Neutropenia (neutrophile count <1000/mm3), Platelet count <25,000 U/µL, Hematopoietic transplant, Solid organ transplant needing immunosuppression, Chemotherapy received in the last 3 months prior to inclusion, Hereditary immunosuppression, Immunomodulatory drugs treatment (TNFα or rituximab) in the prior 3 months or alemtuzumab in the previous 6 months, Oral or intravenous (IV) corticosteroids treatment (>10 mg/day) in the last 30 days, Methotrexate treatment (≥10 mg/s) or azathioprine treatment (≥75 mg/s).
- •Females who are pregnant or breastfeeding.
- •Patients treated with antiviral drugs that are active towards CMV, such as, ganciclovir, valganciclovir, acyclovir, valacyclovir, famciclovir, cidofovir, letermovir, maribavir, brincidofovir) in the last week before inclusion.
- •Patients participating in another clinical trial with an experimental drug.
- •Patients whose life expectancy is 48-72h.
- •Patients with known hypersensitivity to valganciclovir, ganciclovir or any of the excipients.
结局指标
主要结局
Number of days of good outcome during the 30 days follow-up. A good outcome implies that the patient is alive, out of the ICU, with no systemic antimicrobials, no mechanical ventilation, and no SAEs.
Number of days of good outcome during the 30 days follow-up. A good outcome implies that the patient is alive, out of the ICU, with no systemic antimicrobials, no mechanical ventilation, and no SAEs.
次要结局
- Predictive value (specificity, sensibility, cut-off point and area under the curve [AUC]) of Quantiferon-CMV and other immunological markers (total lymphocyte count, CD4/CD8, NK cells, IL-6 and IL-8 levels, serum Immunoglobulin levels) in prediction the presence of viremia.
- Description of immunologic parameters and their ability (specificity, sensibility, cut-off point and AUC) to predict the development of CM infection.
- Comparation of immunological parameters between investigational and placebo groups at inclusion (day 0), end of treatment (day 14) and end of study (day 30).
- Quantification of the following variables: total lymphocyte count, CD4/CD8, NK cells, IL-6 and IL-8 levels, serum Immunoglobulin levels and its correlation with the viral load.
- Quantification of Cmin and Cmax (CMV peak and trough viral load in blood) and their correlation with toxicity (AE, SAEs, etc.) Exclusive for PK substudy population.
- Number of grade 3 or higher AEs related to antiviral drugs.
研究者
FIBHGM
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon
研究点 (5)
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