Cytomegalovirus Infections, Transplantation Infection
Conditions
Keywords
Lung transplantation, Cytomegalovirus infection, Specific immunity
Brief summary
To assess the efficacy of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease.
Detailed description
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.
Interventions
DRUGValganciclovir
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.
DRUGGanciclovir
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.
Sponsors
Instituto de Salud Carlos III
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytomegalovirus disease incidence rate at 18 months after lung transplantation. | 18 months after subject's transplantation. | Cytomegalovirus disease incidence rate at 18 months after lung transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| INFG cut-off point other than 0.2 IU/mL | 18 months after subject's transplantation. | 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. |
Countries
Spain
Outcome results
None listed