CMV Outcomes in Solid Organ Transplant Patients v5.2
Research type
Research Study
Full title
Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study following Solid Organ Transplant (OTUS SOT)
IRAS ID
287712
Contact name
Nizam Mamode
Contact email
Sponsor organisation
Shire Human Genetic Therapies, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
Research Summary:
Cytomegalovirus (CMV) is one of the most common infectious pathogens in transplanted patients. However, contemporary real-world evidence data on CMV infection following solid organ transplant (SOT) is limited. This study will evaluate real-world data in the United States and Europe, with the objective of better understanding the burden of CMV infection and outcomes in SOT participants. It is a multinational, non-intervention, retrospective study, involving only the collection of data, which was previously documented in participants’ medical charts, during routine healthcare. There is no disease or condition being treated, and no tests or procedures will be performed to the included participants.
The main objective of the study is to evaluate and describe the clinical outcomes of CMV infection with current management patterns, including CMV recurrence, response to therapy, graft loss, time to graft loss and participant survival outcomes. In addition, this study is also designed to addressed other secondary objectives, namely: to describe the treatment patterns of CMV management; to describe the participant/clinical characteristics of SOT recipients; and to describe the economic burden and healthcare resource utilization of CMV infection.
Participants who have a diagnosis of CMV infection following a SOT, who were previously treated with at least one anti-CMV agent and are considered resistant, refractory or intolerant to currently available treatment are foreseen to be included in the study.
Participants will be selected in accordance with a set of criteria defined in the study protocol, irrespective of their survival status at the time of collection of the retrospective data from their medical records.Summary or Results:
Background Cytomegalovirus (CMV) infection is a common complication in transplant patients. Modern evidence of clinical practice for the management of CMV after solid organ transplant (SOT) is needed to understand unmet therapeutic needs in this field and reduce this infection’s impact on patients and healthcare systems.
Results
Overall, 218 patients were analyzed from 13 centres. Median time from transplant to first RRI CMV infection was 152 days. Valganciclovir was most commonly used for primary prophylaxis (97.1% of patients). Overall, 90.2% of patients received a valganciclovir-containing regimen as first-line treatment. Foscarnet-containing regimen(s) was used by 64.1% of patients who received second-line treatment (n=64). Overall, 78.9% of patients achieved CMV clearance during the first RRI episode, and 21.6% had CMV recurrence. All-cause mortality was reported in 19.7% of patients. Mortality one year after RRI identification was 11.9%. CMV-related hospitalizations were reported in 47.2% of patients (median length of hospital stay: 10 days). Most hospitalizations (87.0%) were to manage a RRI CMV episode.
Summary
Patients treated with anti-CMV conventional therapies experience new infections, complications, hospitalizations and mortality. Emerging anti-CMV drugs will increase therapeutic options for SOT recipients difficult to treat and will reduce drug-related toxicities.
You may learn more about this study at: SOT:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZk52HXJKF150up5z-2FbBA9D4-2FIPSqnvegeT6XtSJJXU8SnHC89itag8b9SyNel-2FgXyAxJF3rU5BnP7vGBpauvi9ToX3QZuu8iE9rsmRg06zKstaWv35TYtb4YM-2BKdNa2Tr0W-2BQj9MxQB0gXCvGrat6PiBAkW95IDzdnuXz4yvQQk8v28ma7NWp5ceSPKhLDU8w-3D-3DOaJW_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL9wfKYSomx6-2FCCDjZdo-2BLvy-2Bq5CniiVR1gijB45BIPNmGzkNtECcU-2BDDlTyKmXsaN5BxPyGBj0pOU7R34S39es6A0P6dt-2BA3DvEl1xD46qHQI6oZxKgjLZTLBJXzdABV82JMcmLDh5RU9GtHBJ-2FuOW0HdZTLb38nKHxDc4PWNjQw-3D-3D&data=05%7C01%7Cbradfordleeds.rec%40hra.nhs.uk%7C5e3bcc2372d8462d029b08dba93b0a6a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638289843255813721%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=YUdw1FkEhCpC4Lo7lH4B0NFZ8lPmamiaojpZ%2BswZlos%3D&reserved=0
We carried out a retrospective non-interventional medical chart review study in US and European transplant centres between 2020 and 2021 to describe the management and clinical evolution of adult SOT recipients who had a SOT after January 1, 2014 and developed CMV that was resistant, refractory or became intolerant (RRI) to conventional anti-CMV therapies.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
20/YH/0288
Date of REC Opinion
6 Oct 2020
REC opinion
Favourable Opinion