Evidence map›Paper›PMID 37738676›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Immune Monitoring-Guided Versus Fixed Duration of Antiviral Prophylaxis Against Cytomegalovirus in Solid-Organ Transplant Recipients: A Multicenter, Randomized Clinical Trial.

Oriol Manuel, Mirjam Laager, Cédric Hirzel, Dionysios Neofytos, Laura N Walti, Gideon Hoenger, Isabelle Binet, Aurelia Schnyder, Susanne Stampf, Michael Koller and 29 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02538172 (Monitoring of Specific Cytomegalovirus Cell-mediated Immunity), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
8.2field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02538172 nacompletednot on this map

Monitoring of Specific Cytomegalovirus Cell-mediated Immunity (CMV-CMI) for Optimization of Preventive Strategies Against CMV Infection in High-risk Solid-organ Transplant Recipients

TypeinterventionalSponsorUniversity of Lausanne HospitalsRan2015 to 2021Enrolled195ConditionsCytomegalovirus InfectionsArmsT-Track® CMV assay
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. "Innovative diagnostics and treatments of infections in transplantation," report from the 2025Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Article
  6. Interactions Between Immunosuppressive Regimens and Cytomegalovirus Infection After Solid-Organ Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  7. New evidence in the management of CMV infection: impact on prophylaxis and treatment.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Review
  8. Current and Future Strategies for the Prevention and Treatment of Cytomegalovirus Infections in Transplantation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Protocol for the ELISPOT-TC Trial: A Randomized Controlled Study Evaluating CMV-Specific Cellular Immune Monitoring in Heart Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  16. Effector-Memory γδ T Lymphocytes Predict CMV Disease After the Withdrawal of Prophylaxis in Kidney Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  17. Advancements in Cytomegalovirus Management Among Solid Organ Transplant Recipients: Insights From the ESOT CMV Workshop 2023.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  18. Review
  19. Review
  20. Pitfalls in Valganciclovir Prophylaxis Dose Adjustment Based on Renal Function in Kidney Transplant Recipients.Transplant international : official journal of the European Society for Organ Transplantation · 2024
    Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors at 11 institutions in 2 countries.

Oriol ManuelInfectious Diseases Service, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.ORCID 0000-0001-7607-0943
Mirjam LaagerDepartment of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
Cédric HirzelDepartment of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Dionysios NeofytosTransplant Infectious Diseases Unit, University Hospitals Geneva and Faculty of Medicine, Geneva, Switzerland.
Laura N WaltiDepartment of Infectious Diseases, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Gideon HoengerDepartment of Biomedicine, Immunobiology, University of Basel and University Hospital of Basel, Basel, Switzerland.
Isabelle BinetNephrology and Transplantation Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.
Aurelia SchnyderNephrology and Transplantation Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.
Susanne StampfClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Michael KollerClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Matteo MombelliInfectious Diseases Service, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Min Jeong KimClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Matthias HoffmannDivision of Infectious Diseases and Hospital Epidemiology, Kantonsspital St.Gallen, St. Gallen, Switzerland.
Katrin KoenigClinic for Transplantation Immunology and Nephrology, University Hospital Basel, Basel, Switzerland.
Christoph HessDepartment of Biomedicine, Immunobiology, University of Basel and University Hospital of Basel, Basel, Switzerland.
Anne-Valérie BurgenerDepartment of Biomedicine, Immunobiology, University of Basel and University Hospital of Basel, Basel, Switzerland.
Pietro E CippàClinic of Nephrology, University Hospital Zurich, Zurich, Switzerland.
Kerstin HübelClinic of Nephrology, University Hospital Zurich, Zurich, Switzerland.
Thomas F MuellerClinic of Nephrology, University Hospital Zurich, Zurich, Switzerland.
Daniel SidlerDivision of Nephrology and Hypertension, University Hospital Bern, Bern, Switzerland.
Suzan DahdalDivision of Nephrology and Hypertension, University Hospital Bern, Bern, Switzerland.
Franziska Suter-RinikerInstitute for Infectious Diseases, University of Bern, Bern, Switzerland.
Jean VillardDepartment of Immunology and Allergy and Department of Laboratory Medicine, Geneva University Hospital, Geneva, Switzerland.
Andrea ZbindenInstitute of Medical Virology, University of Zurich, Zurich, Switzerland.
Giuseppe PantaleoService of Immunology and Allergy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Nasser SemmoDepartment of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Karine HadayaDepartment of Nephrology and Hypertension, Geneva University Hospitals, Geneva, Switzerland.
Natalia EnríquezTransplant Infectious Diseases Unit, University Hospitals Geneva and Faculty of Medicine, Geneva, Switzerland.
Pascal R MeylanInfectious Diseases Service, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Marc FroissartClinical Trial Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Dela GolshayanTransplantation Center, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Thomas FehrDivision of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel, Basel, Switzerland.
Uyen Huynh-DoDivision of Nephrology and Hypertension, University Hospital Bern, Bern, Switzerland.
Manuel PascualTransplantation Center, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Christian van DeldenTransplant Infectious Diseases Unit, University Hospitals Geneva and Faculty of Medicine, Geneva, Switzerland.
Hans H HirschInfectious Diseases & Hospital Epidemiology, University Hospital of Basel, Basel, Switzerland.
Peter JüniClinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
Nicolas J MuellerDivision of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
Swiss Transplant Cohort Study (STCS)
University Hospital of Basel · CHUniversity of Lausanne · CHUniversity of Basel · CHUniversity Hospital of Geneva · CHKantonsspital St. Gallen · CHUniversity Hospital of Zurich · CHUniversity of Bern · CHUniversity Hospital of Bern · CHEnte Ospedaliero Cantonale · CHUniversity of Oxford · GBUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of assays detecting cytomegalovirus (CMV)-specific T cell-mediated immunity may individualize the duration of antiviral prophylaxis after transplantation.

methodsIn this randomized trial, kidney and liver transplant recipients from 6 centers in Switzerland were enrolled if they were CMV-seronegative with seropositive donors or CMV-seropositive receiving antithymocyte globulins. Patients were randomized to a duration of antiviral prophylaxis based on immune monitoring (intervention) or a fixed duration (control). Patients in the control group were planned to receive 180 days (CMV-seronegative) or 90 days (CMV-seropositive) of valganciclovir. Patients were assessed monthly with a CMV ELISpot assay (T-Track CMV); prophylaxis in the intervention group was stopped if the assay was positive. The co-primary outcomes were the proportion of patients with clinically significant CMV infection and reduction in days of prophylaxis. Between-group differences were adjusted for CMV serostatus.

resultsOverall, 193 patients were randomized (92 in the immune-monitoring group and 101 in the control group), of whom 185 had evaluation of the primary outcome (87 and 98 patients). CMV infection occurred in 26 of 87 (adjusted percentage, 30.9%) in the immune-monitoring group and in 32 of 98 (adjusted percentage, 31.1%) in the control group (adjusted risk difference, -0.1; 95% confidence interval [CI], -13.0% to 12.7%; P = .064). The duration of prophylaxis was shorter in the immune-monitoring group (adjusted difference, -26.0 days; 95%, CI, -41.1 to -10.8 days; P < .001).

conclusionsImmune monitoring resulted in a significant reduction of antiviral prophylaxis, but we were unable to establish noninferiority of this approach on the co-primary outcome of CMV infection. CLINICAL TRIALS REGISTRATION: NCT02538172.

Indexed as

Cytomegalovirus InfectionsOrgan TransplantationAntiviral AgentsCytomegalovirusGanciclovirHumansMonitoring, ImmunologicTransplant RecipientsAntiviral AgentsGanciclovircell-mediated immunitypersonalized medicinepreventiontransplantviral infection

Identifiers

PMID37738676
PMCPMC10874264
OpenAlexW4386948283

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.