Using QuantiFERON-CMV to identify treatment needs for asymptomatic CMV infection in organ transplant recipients
Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients
This study is testing if a blood test can help doctors figure out which organ transplant recipients with a mild CMV infection really need antiviral treatment, so they can avoid unnecessary medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble, Maryland) |
| Trial ID | NCT06341543 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the QuantiFERON-CMV (QF-CMV) assay in identifying solid organ transplant recipients with asymptomatic cytomegalovirus (CMV) infection who may not require antiviral therapy. By measuring specific anti-CMV T lymphocyte immunity, the study seeks to determine which patients are at high risk for severe infection and would benefit from treatment. Participants will include adult organ transplant recipients with a detectable CMV viral load, and the results will guide clinical decisions regarding antiviral treatment. The goal is to reduce unnecessary treatments and their associated side effects and costs.
Who should consider this trial
Good fit: Ideal candidates are adult solid organ transplant recipients with asymptomatic CMV infection and a detectable viral load between 1,000 and 15,000 IU/mL.
Not a fit: Patients currently receiving anti-Herpesviridae treatment or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help identify patients who do not need antiviral therapy, reducing unnecessary treatment and its side effects.
How similar studies have performed: Previous retrospective studies have suggested that similar approaches may be relevant, but this study aims to prospectively assess the utility of the QF-CMV assay, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Grenoble, Maryland
- CHU Grenoble Alpes — Grenoble, Maryland, France (Recruiting)
Study contacts
- Study coordinator: Olivier Epaulard, MD, PhD
- Email: oepaulard@chu-grenoble.fr
- Phone: 0476765291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.