Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial.Paez-Vega, A. et al. (2019).
BMJ Open 9(8): e030648.
This study aims to evaluate the efficacy of reduced prophylaxis (3 months) followed by immuno-guided prophylaxis to prevent cytomegalovirus (CMV) disease in right lung transplant recipients in comparison with the usual strategy of universal prophylaxis (6 months) followed by pre-emptive therapy for 6 months. A second aim of this study is to assess whether, in the patients of experimental group who develop CMV disease, an IFNG cut-off point could predict protection against CMV more reliably.
Patients will be randomized to either the control group (universal prophylaxis and pre-emptive therapy) or the experimental group (reduced prophylaxis and immuno-guided prophylaxis).
Patients that will be recruited into this trial must be lung transplant recipients with positive pre-transplant CMV serology, over 18 years of age, with an expected time of prophylaxis with valganciclovir of 6 months post-transplant and written informed consent.
Primary outcome being assessed is Incidence of CMV disease at 18 months post-transplant and secondary outcome is incidence of CMV replication (excluding replication blips in periods of prophylaxis).
This manuscript describes the protocol for the CYTOCOR study, which investigates the use of Quantiferon-CMV immune monitoring to reduce the duration of CMV prophylaxis required in lung transplant recipients. The study is relevant and interesting, and the protocol is well described. Inclusion and exclusion criteria and outcome definitions are well-described. The study may have relevance to other solid organ transplant types if successful. The sample size estimate is based upon a success rate of 85% in standard practice, but no data or reference is provided to support this assumption. There is also perhaps a missed opportunity, in that the data required for a health economic analysis (resource use and quality of live) is not being collected.
ClinicalTrials.gov - NCT03699254