Infectious Diseases Group, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba, Cordoba, Spain.
Spanish Network for Research in Infectious Diseases (REIPI, RD16/0016/0008), Instituto de Salud Carlos III, Madrid, Spain.
BMJ Open. 2019 Aug 15;9(8):e030648. doi: 10.1136/bmjopen-2019-030648.
Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.
Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.
The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.
NCT03699254.
为了预防肺移植患者发生巨细胞病毒（CMV）疾病而长期使用抗病毒药物已被证明具有显著的副作用，因此正在寻找替代方法来减少其使用。细胞免疫监测 CMV 可能是一种替代方法，因为它已被证明可用于识别感染风险较低的移植患者，这些患者可能受益于较短的预防疗程。CYTOCOR 研究的目的是证明，与常规策略（预防治疗后进行抢先治疗）相比，采用降低预防策略与随后的 CMV 特异性免疫监测相结合，可以有效地控制肺移植患者的 CMV 感染，同时减少抗病毒药物因预防疗程缩短而产生的副作用。
这是一项 III 期随机、开放、多中心、平行、非劣效性临床试验，旨在研究在 CMV 血清阳性肺移植受者中，移植后第 3 个月之前采用预防策略，随后采用 QuantiFERON-CMV 技术进行免疫指导预防，直至移植后第 12 个月，以预防 CMV 疾病。该策略将与移植后第 6 个月之前采用常规预防策略，随后移植后第 12 个月之前采用抢先治疗的策略进行比较。为了研究 CMV 疾病的发生率，将对患者进行随访，随访时间为移植后 18 个月。预计将招募 150 名患者参加这项研究。
该临床试验已获得研究伦理委员会的批准，并获得西班牙药品和医疗器械管理局（AEMPS）的授权。如果这项临床试验的假设得到验证，结果的传播可能会改变临床实践，增加关于在肺移植受者中停止缬更昔洛韦预防的安全性和有效性的知识。
NCT03699254。
