An observational study in Cytomegalovirus Infections, Solid Organ Transplantation Recipient and Solid Organ Transplantation, sponsored by Hospital Italiano de Buenos Aires. Not yet recruiting at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Hospital Italiano de Buenos Aires · Observational
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.
Cytomegalovirus (CMV) remains one of the most frequent infections after solid organ transplantation (SOT), with important direct and indirect effects on graft and patient survival. While preventive strategies (prophylaxis and preemptive therapy) have reduced CMV-related disease and mortality, refractory and resistant CMV infection continues to be a major challenge, particularly in high-risk transplants (donor-positive/recipient-negative serostatus, and those receiving thymoglobulin induction). No epidemiological data on refractory or resistant CMV currently exist in Argentina.
This multicenter retrospective cohort study will include adult (≥18 years) solid organ transplant recipients from participating centers in Argentina who developed CMV infection within 18 months post-transplant, between January 1, 2017 and December 31, 2024. Cases meeting pre-specified operational criteria for refractory or resistant CMV infection will be identified from medical records. Refractory infection is defined as viral load that does not decrease or increases after two weeks of appropriate antiviral treatment; resistant infection is defined as refractory infection with documentation of at least one genetic mutation (UL97 and/or UL54) associated with antiviral resistance, confirmed through genotyping performed at the national reference laboratory (Instituto Malbrán).
Data will include demographic and transplant-related variables, immunosuppression regimen, virological monitoring, antiviral treatment lines and dosing, resistance genotyping results when available, and clinical outcomes including graft function, rejection episodes, and mortality at 90 days and one year. Data will be collected, coded, and stored in a centralized, de-identified database (REDCap) for descriptive and comparative statistical analysis.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 93 observational studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
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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.
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Exclusion Criteria:
Adult solid organ transplant recipients (kidney, liver, heart, lung, pancreas, or combined transplants) who developed CMV infection within 18 months post-transplant between 2017 and 2024, followed to identify episodes meeting criteria for refractory or resistant infection
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)
Time frame: Within 18 months post-transplant, assessed retrospectively for the period January 2017 to December 2024
Incidence of overall CMV infection
Proportion of SOT recipients with any CMV infection (primary infection, reactivation, asymptomatic infection, or disease), stratified by transplanted organ
Time frame: Within 18 months post-transplant, 2017-2024
Distribution of clinical forms of CMV infection
Classification of CMV episodes as primary infection, reactivation, asymptomatic infection, or CMV disease
Time frame: Within 18 months post-transplant, 2017-2024
Frequency of antiviral resistance mutations
Proportion of genotyped refractory CMV episodes with ≥1 resistance-associated mutation (UL97 and/or UL54)
Time frame: From T3 (declaration of refractoriness) to T4 (episode resolution), up to 12 months
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)
Time frame: From T2 (treatment initiation) to T4 (negativization) or last available PCR if not resolved, up to 12 months
All-cause mortality
Proportion of patients who died at 90 days and at 1 year after the CMV refractory/resistant episode
Time frame: 90 days and 1 year post-episode onset
Graft outcome
Proportion of patients with graft loss or rejection following the CMV refractory/resistant episode
Time frame: rejection following the CMV refractory/resistant episode Through 1 year post-episode onset
Association between mutation type and antiviral treatment received
Distribution of antiviral treatment regimens received (ganciclovir, foscarnet, letermovir, maribavir, cidofovir, combination therapy) according to mutation type detected (UL97 vs. UL54 vs. none)
Time frame: From T2 (antiviral treatment initiation) to T4 (episode resolution), up to 12 months
Virologic response
Time to virologic negativization (two consecutive negative PCR results ≥7 days apart)
Time frame: From T2 (treatment initiation) to T4 (confirmed negativization), up to 12 months, with censoring at last available PCR for patients not achieving negativization
Plan to share: No — Individual participant data will not be shared. Study data are de-identified and coded using a randomly generated numeric key, in accordance with Argentine Personal Data Protection Law 25.326/00 (Habeas Data) and institutional confidentiality requirements. Access is restricted to the principal investigator, and the database will be deleted upon completion of the statistical analysis.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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