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

22 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

200

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Argentine
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentine, 1199
        • Hospital Italiano de Buenos Aires
        • Sous-enquêteur:
          • Emilio Felipe Huaier Arriazu, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Astrid Smud, MD
        • Chercheur principal:
          • Laura Alicia Barcan, MD
        • Sous-enquêteur:
          • Natalia Pujato, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of refractory or resistant CMV infection
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of overall CMV infection
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Italiano de Buenos Aires

Collaborateurs

Takeda Pharmaceuticals North America, Inc.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 janvier 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

26 juillet 2026

Première soumission répondant aux critères de contrôle qualité

22 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 7752 (CTEP)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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