Prospective study to evaluate the efficacy of letermovir prophylaxis for the prevention of CMV infection in lung transplant recipients compared to a retrospective cohort treated with standard valganciclovir prophylaxis for 12 months (LETERCOR Study)

Conditions

lung transplant patients (D+/R-)

Brief summary

Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.

Detailed description

Administered doses of Letermovir or Valganciclovir, CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins), Changes in the patient's medication directly related to the toxicity of CMV antivirals, Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL), Hospital readmission associated with CMV complications, Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period, Incidence of renal toxicity directly related to CMV antivirals, Rate of patients achieving functional CMV-specific cell-mediated immunity (CMI-CMV) levels after receiving letermovir prophylaxis during the 6 months following discontinuation., Rate of CMV-seropositive patients after receiving letermovir prophylaxis during the 6 months following discontinuation

Related papers

No related papers found yet.

Interventions

DRUGPREVYMIS 240 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of CMV disease/replication for 12 months after initiation of prophylaxis.	—

Secondary

Measure	Time frame
Administered doses of Letermovir or Valganciclovir, CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins), Changes in the patient's medication directly related to the toxicity of CMV antivirals, Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL), Hospital readmission associated with CMV complications, Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period, Incidence of renal toxicity directly related to CMV antivirals, Rate of patients achieving functional CMV-specific cell-mediated immunity (CMI-CMV) levels after receiving letermovir prophylaxis during the 6 months following discontinuation., Rate of CMV-seropositive patients after receiving letermovir prophylaxis during the 6 months following discontinuation	—

Measure

Time frame

Administered doses of Letermovir or Valganciclovir, CMV Medications: Any non-antiviral therapy received as SoC for CMV management (eg immunoglobulins), Changes in the patient's medication directly related to the toxicity of CMV antivirals, Incidence of leukopenia. (Leukopenia will be considered if the total leukocyte number is less than 3,000/mL and neutropenia if the total neutrophil number is less than 1,000/mL), Hospital readmission associated with CMV complications, Incidence of opportunistic viral, bacterial, or fungal infections during the study follow-up period, Incidence of renal toxicity directly related to CMV antivirals, Rate of patients achieving functional CMV-specific cell-mediated immunity (CMI-CMV) levels after receiving letermovir prophylaxis during the 6 months following discontinuation., Rate of CMV-seropositive patients after receiving letermovir prophylaxis during the 6 months following discontinuation

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Countries

Spain

Outcome results

None listed