Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

Maimónides Biomedical Research Institute of Córdoba150 enrolled

Overview

To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.

Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Transplantation Infection Cytomegalovirus Infections

Interventions

ValganciclovirDRUG

Valganciclovir is a L-valyl ester of ganciclovir that exists as a mix of 2 diastereomers. After administration, both are converted to ganciclovir by esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus. In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate.

GanciclovirDRUG

Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus. In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with cytomegalovirus positive serology who underwent lung transplantation. * Subjects of 18 years of age or older. * Expected valgancilovir prophylactic treatment of 6 months after transplantation. * Patients who have signed the informed consent form. Exclusion Criteria: * HIV infected subjects. * Subjects unable to comply with the protocolo follow-up visits. * Subjects who underwent multivisceral transplant. * Pregnant and/or lactating women. * Intolerance to Valganciclovir/Ganciclovir treatment.

Locations (7)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario de A Coruña

A Coruña, Spain

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Outcomes

Primary Outcomes

Cytomegalovirus disease incidence rate at 18 months after lung transplantation.

Time frame: 18 months after subject's transplantation.

Secondary Outcomes

INFG cut-off point other than 0.2 IU/mL

For patients of the experimental group (3+9) in which immuno-guided prophylaxis is used based on QF-CMV Reactive (cut-off 0.2 IU/mL of IFNG) and who develop CMV disease, a secondary objective will be to assess whether an INFG cut-off point other than 0.2 IU/mL could predict protection against the disease more reliably.

Time frame: 18 months after subject's transplantation.

Data from ClinicalTrials.gov

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