Effectiveness of a preventive strategy for cytomegalovirus infection guided differently from a universal prophylactic strategy in kidney transplant patients - CYTOPREV

Conditions

CMV

Brief summary

Proportion of patients with CMV infection within 6 months of transplantation.

Detailed description

Proportion of patients requiring the use of curative antiviral treatment within 6 months after transplantation, Proportion of patients with CMV disease within 6 months of transplantation, Proportion of patients with CMV infection (CMV DNAemia ≥ 305 IU/mL (= 2.3 log IU/mL), CMV infection (CMV DNAemia ≥ 4 log IU/mL requiring curative treatment or CMV disease within the first year following transplant, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+15, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+28, CMV serological status of the donor (D+/R+ versus D-/R+), Incremental cost-effectiveness ratio will be calculated for the period from randomization to the visit at S+28 post-transplantation for the experimental group (Arm ) compared to the comparator group (Arm ) with the average costs and efficacies for each strategy. The incremental cost-effectiveness ratio will be presented as additional cost per CMV infection avoided.

Related papers

No related papers found yet.

Interventions

DRUGVALGANCICLOVIR VIATRIS 450 mg

DRUGcomprimé pelliculé

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with CMV infection within 6 months of transplantation.	—

Secondary

Measure	Time frame
Proportion of patients requiring the use of curative antiviral treatment within 6 months after transplantation, Proportion of patients with CMV disease within 6 months of transplantation, Proportion of patients with CMV infection (CMV DNAemia ≥ 305 IU/mL (= 2.3 log IU/mL), CMV infection (CMV DNAemia ≥ 4 log IU/mL requiring curative treatment or CMV disease within the first year following transplant, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+15, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+28, CMV serological status of the donor (D+/R+ versus D-/R+), Incremental cost-effectiveness ratio will be calculated for the period from randomization to the visit at S+28 post-transplantation for the experimental group (Arm ) compared to the comparator group (Arm ) with the average costs and efficacies for each strategy. The incremental cost-effectiveness ratio will be presented as additional cost per CMV infection avoided.	—

Measure

Time frame

Proportion of patients requiring the use of curative antiviral treatment within 6 months after transplantation, Proportion of patients with CMV disease within 6 months of transplantation, Proportion of patients with CMV infection (CMV DNAemia ≥ 305 IU/mL (= 2.3 log IU/mL), CMV infection (CMV DNAemia ≥ 4 log IU/mL requiring curative treatment or CMV disease within the first year following transplant, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+15, Number of CMV-specific T lymphocytes (IE-1 and pp65) at W+28, CMV serological status of the donor (D+/R+ versus D-/R+), Incremental cost-effectiveness ratio will be calculated for the period from randomization to the visit at S+28 post-transplantation for the experimental group (Arm ) compared to the comparator group (Arm ) with the average costs and efficacies for each strategy. The incremental cost-effectiveness ratio will be presented as additional cost per CMV infection avoided.

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Countries

France

Outcome results

None listed