This study will describe the frequency and characteristics of refractory and resistant cytomegalovirus (CMV) infection in adults who received a solid organ transplant in Argentina between 2017 and 2024. Researchers will review medical records from transplant centers across the country to identify episodes of CMV infection that did not respond adequately to standard antiviral treatment (refractory) or that showed genetic mutations associated with drug resistance. The study will describe the clinical features, treatments used, and outcomes (including graft function and survival) of patients with these episodes, in order to better understand how common this problem is and what factors are associated with it in the local population.
Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined) at a participating center in Argentina between January 1, 2017 and December 31, 2024
Documented CMV infection within 18 months post-transplant
Followed for at least 18 months from transplant and at least 12 months from CMV infection onset
Patients with incomplete medical records precluding assessment of CMV infection status or key study variables
Patients not meeting the minimum follow-up period from transplant or from infection onset
Adult patients (≥18 years) who received a solid organ transplant (kidney, liver, heart, lung, pancreas, or combined transplant) at one of the participating centers in Argentina, and who developed cytomegalovirus (CMV) infection within 18 months following transplantation, during the period from January 1, 2017 to December 31, 2024. Cases are identified retrospectively from the transplant databases and medical records of each participating center.
Cohort
Retrospective
Not listed
Incidence of refractory or resistant CMV infection
Proportion of solid organ transplant recipients with CMV infection who meet operational criteria for refractory infection (viral load unchanged or increased after 2 weeks of appropriate antiviral treatment) or resistant infection (refractory infection plus documented genetic mutation, e.g. UL97 and/or UL54, associated with antiviral resistance)
Incidence of overall CMV infection
Proportion of SOT recipients with any CMV infection (primary infection, reactivation, asymptomatic infection, or disease), stratified by transplanted organ
Distribution of clinical forms of CMV infection
Classification of CMV episodes as primary infection, reactivation, asymptomatic infection, or CMV disease
Frequency of antiviral resistance mutations
Proportion of genotyped refractory CMV episodes with ≥1 resistance-associated mutation (UL97 and/or UL54)
Antiviral treatment lines and combination therapy use
Number of antiviral treatment lines used per episode (1, 2, ≥3) and proportion of episodes receiving combination antiviral therapy (≥2 active agents ≥72h)
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Hospital Italiano de Buenos Aires
Lead sponsor
Takeda Pharmaceuticals North America, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
