Status:
COMPLETED
Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T Cells Immunomonitoring.
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Kidney Transplant Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction...
Detailed Description
The study aim to demonstrate that the expansion of γδ T cells at the end of curative treatment predicts the absence of virological and clinical relapses. This is a pilot study that will be conducted i...
Eligibility Criteria
Inclusion
- Male or female over 18 years old without weight or ethnicity criteria, kidney transplant.
- Patient affiliated or beneficiary of a social security scheme.
- Patient with symptomatic or non-symptomatic CMV infection requiring curative treatment with ganciclovir or valganciclovir.
- Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research).
Exclusion
- Resistance documented to antivirals.
- Hemodialysis patient.
- Number of polymorphonuclear neutrophils less than 500 / μL and / or number of platelets less than 25,000 / μL, and / or lower hemoglobin 8 g / dL.
- Contraindication to valganciclovir, including known hypersensitivity to valganciclovir and / or aciclovir and / or valaciclovir or ganciclovir or their excipients, known severe intolerance to valganciclovir or ganciclovir.
- Women of childbearing age without a negative pregnancy test at baseline and without effective contraception (estrogen-progestin, intrauterine device) throughout the study period and two months after cessation of the follow-up period.
- Nursing women.
- Men without mechanical contraception during treatment and for at least 90 days after treatment.
- Ongoing participation in another clinical trial evaluating a drug. Participation in an observational study will not be considered a contraindication.
- The patient's foreseeable inability to comply with planned visits in the protocol.
- Non-negativation of CMV PCR at 8 weeks
Key Trial Info
Start Date :
November 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03339661
Start Date
November 23 2017
End Date
November 23 2020
Last Update
June 7 2021
Active Locations (2)
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1
Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France, 33000
2
Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France, 69003