CMV infection in transplantation
Conditions
Interventions
Product Name: CYTOTECT CP BIOTEST 100 U/mL
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man or woman over 18 years old, 2) Patient candidate for a first transplant or re-transplantation, registered on the national waiting list of the Biomedicine Agency. 3) Patients seropositive for CMV (positive serology during the pre-transplant assessment or on D0 transplant) 4) Patients receiving a kidney transplant from a deceased donor or a living donor. 5) Women of childbearing age presenting a negative pregnancy test on inclusion and giving their consent to the establishment of effective contraception throughout the study period and two months after stopping the period of monitoring. 6) Patient affiliated or beneficiary of a social security insurance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: 1) Patients seronegative for CMV (R-). 2) Historical or current Incompatible Graft rate (TGI)> 85%. 3) Patients who received anti-CMV treatment within 28 days of transplantation. 4) Indication for induction therapy with anti-lymphocyte globulin, rituximab, polyvalent intravenous immunoglobulins or any other immunomodulatory molecule, and treatment with inhibitor mTOR, themselves described associated with a decrease in the incidence of CMV infections 5) Patients who have received or are receiving a solid organ transplant other than a kidney transplant. 6) Patients known to be seropositive for human immunodeficiency virus (HIV), hepatitis B virus (HBV; Ag HbS positive) or hepatitis C virus (HCV; anti-HCV antibodies positive), 7) Allergy, contraindication or known intolerance to specific anti-CMV Ig, mycophenolic acid, basiliximab, corticosteroids, cyclosporine A, tacrolimus or to excipients of these products. 8) Any form of substance abuse, psychiatric disorder or any condition, which, according to the investigator, may complicate communication during follow-up. 9) Foreseeable inability to comply with the visits / check-ups planned in the protocol. 10) Patients under guardianship / curatorship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the association between the level of gamma-delta Vdelta2 negative T lymphocytes (LTgdVd2neg) expressing CD16 in peripheral blood on the day of transplantation and the occurrence of an infection with CMV within one year of transplantation in patients with positive CMV (R +) serology prior to kidney transplantation and receiving CMV prophylaxis by infusion of CMV-specific immunoglobulins.;Secondary Objective: - To assess the association between the level of gamma-delta Vdelta2 negative T lymphocytes expressing CD16 in peripheral blood on the day of transplantation and the occurrence of CMV disease during the year following transplantation in patients with positive CMV serology before renal transplantation and receiving anti-CMV prophylaxis by infusion of CMV-specific immunoglobulins. - To determine a threshold of LTgdVd2neg CD16 + predictive of an effective therapeutic response to anti-CMV Ig in R + patients in preventive treatment of post-transplant CMV infection - Determine the percentage of NK lymphocytes in peripheral blood expressing CD16, which may be associated with protection from CMV infection after infusion of anti-CMV Ig - Describe the phenotypic kinetics of LTgd and NK lymphocytes in patients receiving anti-CMV Ig.;Primary end point(s): The primary outcome measure is the association between the LTgd CD16 + level on the day of transplantation and the occurrence of CMV infection in the year following transplantation.;Timepoint(s) of evaluation of this end point: 12 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) the association between the level of LTgdVd2neg CD16 + in the peripheral blood on the day of transplantation and the occurrence of CMV disease in the year after transplantation. 2) the value of LTgdVd2neg CD16 + in peripheral blood on the day of transplantation associated with the absence of CMV infection during the year after transplantation. 3) the association between the level of NK lymphocytes, another cell population expressing CD16, and the occurrence of CMV infection in the year following transplantation. 4) the kinetics of the phenotype of LTgdVd2neg CD16 + and NK in peripheral blood at one year of post-transplantation follow-up. 5) comparison of the incidence of CMV infection in the group of patients in this study compared to that in a historical group of R + patients in preemptive follow-up without CMV Ig.;Timepoint(s) of evaluation of this end point: All secondary endpoints will be assessed 12 months after inclusion | — |
Countries
France
Contacts
Public ContactKAMINSKI
CHU de Bordeaux
Outcome results
None listed