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BMJ Open. 2019 Aug 15;9(8):e030648. doi: 10.1136/bmjopen-2019-030648.

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.

Author information

1
Infectious Diseases Group, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba, Cordoba, Spain.
2
Spanish Network for Research in Infectious Diseases (REIPI, RD16/0016/0008), Instituto de Salud Carlos III, Madrid, Spain.
3
Infectious Diseases Group, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofía University Hospital/University of Cordoba, Cordoba, Spain sacanti@hotmail.com.
4
Infectious Diseases Unit, Reina Sofía University Hospital, Cordoba, Spain.
5
Thoracic Surgery and Lung Transplantation Unit, Reina Sofía University Hospital, Cordoba, Spain.
6
Clinical Trial Unit, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)/Reina Sofía University Hospital/University of Córdoba (SCReN PT17/0017/0032), Cordoba, Spain.
7
Clinical Trial Unit, Virgen del Rocío University Hospital (CTU-HUVR), (SCReNPT13/0002/0010-PT17/0017/0012), Sevilla, Spain.
8
Microbiology Unit, Reina Sofía University Hospital, Cordoba, Spain.
9
Neumology Service, Instituto de Investigación i+12 Hospital Universitario 12 de Octubre. (REIPI, RD16/0016/0002), Madrid, Spain.
10
Neumology Service, University Hospital Marqués de Valdecilla-IDIVAL (REIPI, RD16/0016/0007), Santander, Spain.
11
Respiratory Department, Vall d' Hebron Barcelona Hospital Campus. Universitat Autónoma de Barcelona, (REIPI, RD16/0016/0003), Barcelona, Spain.
12
Ciber Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
13
Neumology Service, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC) Sergas Universidade da Coruña (UDC), (REIPI, RD16/0016/0006), As Xubias, A Coruna, Spain.
14
Lung Transplant Unit, La Fe University and Polytechnic Hospital, Valencia, Spain.
15
Neumology Service, Puerta de Hierro-Majadahonda University Hospital, Majadahonda, Spain.

Abstract

INTRODUCTION:

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.

METHODS AND ANALYSIS:

Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.

ETHICS AND PUBLIC DISSEMINATION:

The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.

TRIAL REGISTRATION NUMBER:

NCT03699254.

KEYWORDS:

cytomegalovirus; immuno-guided prophylaxis; lung transplantation

Conflict of interest statement

Competing interests: J.T.C. and S.C. have received an unrestricted research grant from Roche Pharma and Qiagen. They have also received payments from Qiagen for educational activities.

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