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

Cytomegalovirus Infections Clinical Trial

— CYTOCOR  

Official title:

Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis to Prevent Cytomegalovirus Disease in Lung Transplant Recipients (CYTOCOR STUDY): An Open-label, Randomised, Non-inferiority Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699254
• Other study ID #: CYTOCOR
• Secondary ID: 2018-003300-39
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2019
• Est. completion date: May 29, 2023

Study information

• Verified date: September 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 29, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• Infections
• Transplantation Infection

Intervention

Drug:
• Valganciclovir
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.
• Ganciclovir
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital Universitario Vall D'Hebron	Barcelona
Spain	Hospital Univesitario Reina Sofía	Córdoba
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cytomegalovirus disease incidence rate at 18 months after lung transplantation.	Cytomegalovirus disease incidence rate at 18 months after lung transplantation.	18 months after subject's transplantation.
Secondary	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.	18 months after subject's transplantation.