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CMV Refractory and Resistant Infection in Solid Organ Transplant Recipients in Argentina

22 augustus 2026 bijgewerkt door: EMILIO FELIPE HUAIER ARRIAZU, Hospital Italiano de Buenos Aires

Evaluation of Cytomegalovirus Refractoriness and Resistance in Solid Organ Transplantation in Argentina: A Multicenter Study

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Argentinië
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentinië, 1199
        • Hospital Italiano de Buenos Aires
        • Onderonderzoeker:
          • Emilio Felipe Huaier Arriazu, MD
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Astrid Smud, MD
        • Hoofdonderzoeker:
          • Laura Alicia Barcan, MD
        • Onderonderzoeker:
          • Natalia Pujato, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
CMV-infected SOT recipients
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of refractory or resistant CMV infection
Tijdsspanne: Within 18 months post-transplant, assessed retrospectively for the period January 2017 to December 2024
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)
Within 18 months post-transplant, assessed retrospectively for the period January 2017 to December 2024

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of overall CMV infection
Tijdsspanne: Within 18 months post-transplant, 2017-2024
Proportion of SOT recipients with any CMV infection (primary infection, reactivation, asymptomatic infection, or disease), stratified by transplanted organ
Within 18 months post-transplant, 2017-2024
Distribution of clinical forms of CMV infection
Tijdsspanne: Within 18 months post-transplant, 2017-2024
Classification of CMV episodes as primary infection, reactivation, asymptomatic infection, or CMV disease
Within 18 months post-transplant, 2017-2024
Frequency of antiviral resistance mutations
Tijdsspanne: From T3 (declaration of refractoriness) to T4 (episode resolution), up to 12 months
Proportion of genotyped refractory CMV episodes with ≥1 resistance-associated mutation (UL97 and/or UL54)
From T3 (declaration of refractoriness) to T4 (episode resolution), up to 12 months
Antiviral treatment lines and combination therapy use
Tijdsspanne: From T2 (treatment initiation) to T4 (negativization) or last available PCR if not resolved, up to 12 months
Number of antiviral treatment lines used per episode (1, 2, ≥3) and proportion of episodes receiving combination antiviral therapy (≥2 active agents ≥72h)
From T2 (treatment initiation) to T4 (negativization) or last available PCR if not resolved, up to 12 months
All-cause mortality
Tijdsspanne: 90 days and 1 year post-episode onset
Proportion of patients who died at 90 days and at 1 year after the CMV refractory/resistant episode
90 days and 1 year post-episode onset
Graft outcome
Tijdsspanne: rejection following the CMV refractory/resistant episode Through 1 year post-episode onset
Proportion of patients with graft loss or rejection following the CMV refractory/resistant episode
rejection following the CMV refractory/resistant episode Through 1 year post-episode onset
Association between mutation type and antiviral treatment received
Tijdsspanne: From T2 (antiviral treatment initiation) to T4 (episode resolution), up to 12 months
Distribution of antiviral treatment regimens received (ganciclovir, foscarnet, letermovir, maribavir, cidofovir, combination therapy) according to mutation type detected (UL97 vs. UL54 vs. none)
From T2 (antiviral treatment initiation) to T4 (episode resolution), up to 12 months
Virologic response
Tijdsspanne: From T2 (treatment initiation) to T4 (confirmed negativization), up to 12 months, with censoring at last available PCR for patients not achieving negativization
Time to virologic negativization (two consecutive negative PCR results ≥7 days apart)
From T2 (treatment initiation) to T4 (confirmed negativization), up to 12 months, with censoring at last available PCR for patients not achieving negativization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Italiano de Buenos Aires

Medewerkers

Takeda Pharmaceuticals North America, Inc.

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

30 januari 2027

Studie voltooiing (Geschat)

1 maart 2027

Studieregistratiedata

Eerst ingediend

26 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 augustus 2026

Eerst geplaatst (Werkelijk)

26 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

22 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 7752 (CTEP)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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