Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL)
研究概览
简要总结
Context
Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.
Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy.
As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).
Aim of the study
The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.
Methods
Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL.
The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).
- In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.
- in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.
In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).
The participants will be sampled:
- 5 to 12 days after QF-CMV sampling (V2) ;
- 7 to 14 days days after V2 (V3 - between D12 and D26) ;
- 7 to 14 days days after V3 (V4 - between D19 and D40) .
Endpoints
The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:
- Blood CMV viral load >10,000 IU/mL [4 log];
- And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise >5000 IU/mL;
- And/or the onset of CMV disease.
The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).
详细描述
Context.
Solid organ transplant (SOT) recipients are at high risk of opportunistic infections, particularly due to cytomegalovirus (CMV).
Regarding CMV infection after transplantation, two approaches are possible: either antiviral prophylaxis for several months, followed by monitoring of blood CMV viral load (or viremia), or immediate monitoring of viral load without prophylaxis.
In both cases, the detection of a CMV viral load raises a complex question: is antiviral treatment necessary? Indeed, not all viremia leads to CMV disease: some patients spontaneously control their viremia.
In order to limit unnecessary treatments, their toxicity and their cost, new tools are needed to identify people at high risk of developing a high viral load or CMV disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years.
- •Solid organ transplant recipient (heart, kidney, liver and lung)
- •Detectable CMV viral load between 1,000 and 15,000 IU/mL (including 2 borderline values):
- •Asymptomatic (no fever or organ dysfunction) ;
- •Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;
- •Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.
- •Having signed an informed consent form.
- •Affiliated to a social security scheme.
排除标准
- •Presence of anti-Herpesviridae treatment when CMV replication is detected ([val]aciclovir, [val]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).
- •Pregnant or breast-feeding women.
- •Persons under guardianship or trusteeship.
- •Subjects under administrative or judicial supervision.
- •Subject unable to be contacted in case of emergency.
结局指标
主要结局
proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL)
时间窗: 5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection
Uncontrolled infection 5 to 12 days after QF-CMV sampling is defined as follows: * Blood CMV viral load \>10,000 IU/mL \[4 log\]; * And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL
proportion of participants with CMV disease
时间窗: 5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection
CMV disease is defined as follows: * pneumonia onset * colitis onset * encephalitis onset * hepatitis onset
次要结局
- proportion of participants with antiviral-associated anemia(5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection)
- proportion of participants with antiviral-associated tubulotoxicity (hypokaliemia)(5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection)
- proportion of participants with antiviral-associated thrombopenia(5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection)
- proportion of participants with antiviral-associated leucopenia(5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection)
- antiviral-associated kidney failure (creatininemia)(5 to 12 days after QF-CMV sampling, and up to 40 days after first CMV detection)