Clinical trial NCT03699254: Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transplantation Infection
Cytomegalovirus Infections
Keywords: Lung transplantation
Cytomegalovirus infection
Specific immunity
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2018-10-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cytomegalovirus disease incidence rate at 18 months after lung transplantation.
timeFrame: 18 months after subject's transplantation.
Secondary outcomes:
measure: INFG cut-off point other than 0.2 IU/mL
timeFrame: 18 months after subject's transplantation.
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Córdoba
country: Spain
facility: Hospital Univesitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Julián de la Torre Cisneros, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.
citation: Paez-Vega A, Cantisan S, Vaquero JM, Vidal E, Luque-Pineda A, Lobo-Acosta MA, Perez AB, Alonso-Moralejo R, Iturbe D, Monforte V, Otero-Gonzalez I, Pastor A, Ussetti P, Torre-Cisneros J. 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. BMJ Open. 2019 Aug 15;9(8):e030648. doi: 10.1136/bmjopen-2019-030648.