Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06341543

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

Led by University Hospital, Grenoble · Updated on 2024-10-01

288

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL. The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation). * In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices. * in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive. In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect). The participants will be sampled: * 5 to 12 days after QF-CMV sampling (V2) ; * 7 to 14 days days after V2 (V3 - between D12 and D26) ; * 7 to 14 days days after V3 (V4 - between D19 and D40) . Endpoints The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows: * Blood CMV viral load \>10,000 IU/mL \[4 log\]; * And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL; * And/or the onset of CMV disease. The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Recipient of a solid organ transplant (heart, kidney, liver, or lung)
  • Detectable asymptomatic CMV viral load between 1,000 and 15,000 IU/mL
  • Occurrence of CMV infection within 2 years after transplantation without primary anti-CMV prophylaxis, or within 2 years after stopping such prophylaxis
  • Signed informed consent form
  • Affiliated with a social security scheme
Not Eligible

You will not qualify if you...

  • Receiving anti-Herpesviridae treatment at time of CMV replication detection (e.g., (val)aciclovir, (val)ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, brincidofovir)
  • Pregnant or breastfeeding women
  • Persons under guardianship or trusteeship
  • Subjects under administrative or judicial supervision
  • Unable to be contacted in case of emergency

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Grenoble Alpes

Grenoble, Maryland, France, 38043

Actively Recruiting

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Research Team

O

Olivier Epaulard, MD, PhD

CONTACT

M

Martine Pernollet, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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