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Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Grenoble
NCT06341543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Context Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients. Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy. As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France). Aim of the study The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy. Methods Participation to the study w

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Solid organ transplant recipient (heart, kidney, liver and lung) * Detectable CMV viral load between 1,000 and 15,000 IU/mL (including 2 borderline values): * Asymptomatic (no fever or organ dysfunction) ; * Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis; * Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used. * Having signed an informed consent form. * Affiliated to a social security scheme. Exclusion Criteria: * Presence of anti-Herpesviridae treatment when CMV replication is detected (\[val\]aciclovir, \[val\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir). * Pregnant or breast-feeding women. * Persons under guardianship or trusteeship. * Subjects under administrative or judicial supervision. * Subject unable to be contacted in case of emergency.
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What it tests

  • Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes).
  • Communication of the result of the QF-CMV to the clinician in charge
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Where

1 site
CHU Grenoble Alpes
Grenoble, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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