A Multicenter Prospective Observational Study to Evaluate Cytomegalovirus (CMV)-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients With CMV-positive Serology (R+) Prior to Transplant and Its Involvement in the Development of CMV Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 7
- 主要终点
- Quantification of interferon-γ produced by specific CD8+ (cluster of differentiation 8) T cells after ex-vivo stimulation with various CMV epitopes using the commercial assay QuantiFeron®- CMV
研究概览
简要总结
The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and ImmuKnow® in combination for early detection of patients who will develop CMV infection in lung transplant patients with CMV-positive serology (R+) prior to transplant.
详细描述
The secondary objectives of the study are:
- To evaluate Cytomegalovirus (CMV)-specific immune response measured by QuantiFeron®.
- To evaluate overall immune response measured by ImmuKnow®.
- To study the course of QuantiFeron® and ImmuKnow®over the follow-up period.
- To correlate levels of ImmuKnow® and QuantiFeron®.
- To evaluate the relationship between levels and doses of immunosuppressants and their relationship to degree of overall immunosuppression (ImmuKnow®).
- To evaluate the relationship between infections, immunological complications and degree of overall immunosuppression (ImmuKnow®).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients aged ≥ 18 years.
- •Men or women who have received a lung transplant.
- •CMV-seropositive patients (R+).
- •Patients who have been informed of the study procedures and have signed the informed consent form.
- •Over 3 months posttransplant.
排除标准
- •Patients who are not expected to be able to be followed during the first 12 months posttransplant.
- •Patient participation in another clinical trial or study will not be a criterion for exclusion.
结局指标
主要结局
Quantification of interferon-γ produced by specific CD8+ (cluster of differentiation 8) T cells after ex-vivo stimulation with various CMV epitopes using the commercial assay QuantiFeron®- CMV
时间窗: up to 12 months from transplant
Quantiferon® is assessed multiple times and it will be considered positive when first positive test is assessed.
Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells
时间窗: up to 12 months from transplant
InmunKnow® is assessed multiple times and it will be considered positive when first positive test is assessed.
Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction)
时间窗: up to 12 months from transplant
PCR is assessed multiple times and it will be considered positive when first positive test is assessed.
次要结局
- Course of graft function by measuring GFR (glomerular filtration rate)(up to 12 months from transplant)
- Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications(up to 12 months from transplant)
- Measurement of immunosuppressive drugs: Blood levels of calcineurin inhibitors (tacrolimus or cyclosporine). Mycophenolate (or equivalent) dose and corticosteroid doses.(up to 12 months from transplant)
- Determination of glomerular filtration rate(up to 12 months from transplant)
- CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug(up to 12 months from transplant)
- Complete blood count (WBC count) and routine biochemistry(up to 12 months from transplant)
- Follow-up loss/death (if it occurs)(up to 12 months from transplant)
研究者
Victor Monforte
Hospital Vall d'Hebron
Fundacio Catalana de Pneumologia