An observational study in Cytomegalovirus Infections and Solid Organ Transplantation, sponsored by University Hospital, Bordeaux. Active, not recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by University Hospital, Bordeaux · Observational
CMV disease remains the most frequent infectious complication post-transplant and it is associated to high morbidity and even mortality. Global efforts from both transplant physicians and researchers in the field is needed to better characterize the host-virus interactions in the transplant setting, with the aim of decreasing the burden of disease and improve the well-being of patients.
"HORUS" (Casting light on HOst-cytomegaloviRUs interaction in Solid organ transplantation) study is a European research project, funded by the European Commission (Horizon Europe) involving 16 partners in seven European countries (France, Spain, Czech Republic, Belgium, Switzerland, Germany and Italy) aiming to better characterize the host-CMV interactions in SOT recipients. The first aim of HORUS study will be to build a European cohort of SOT recipients including clinical characterization and the constitution of a biocollection, which is the aim of HORUS cohort, in order to perform biological, immunological, gene expression, viral kinetics and deep viral genome characterization in the global European HORUS project to improve our understanding of the development of a CMV immune response in the context of immunosuppression.
The overall goal of HORUS study is to improve our understanding of the host-virus relationship of Cytomegalovirus within immunocompromised solid organ transplant recipients in order to propose both knowledge improvement, and clinical immune signatures for decreasing CMV infections/diseases incidence and avoiding the use of toxic antiviral therapy. HORUS' general goal is to enhance our knowledge on risk factors, disease progression and clinical outcomes by analyzing together immune host characteristics, viral characteristics and immunosuppressive drugs. The constitution of two clinical cohorts ("The day 0 of graft cohort" and "the day 0 of infection cohort") will constitute the aim of "HORUS study" with clinical data collection and biocollection which will be used in the global HORUS project to identify immune profiles of patients integrating all the actors involved in viral control, viral and clinical parameters associated with a higher risk of CMV replication and an evolution toward a CMV difficult-to-treat disease.
"HORUS cohorts" is a project of biological samples biobank from solid organ transplant recipients in Hospitals : France (Bordeaux, Toulouse, Paris, Lyon), Spain (Barcelona), Tchequie (Karlova), Italy (Bologna), Switzerland (Lausanne).
Its main objective of this protocol is to collect, prepare, and store
The secondary objective is to support for the global "HORUS" project aiming at:
359 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.
This study's enrollment of 552 is above the median of 150 across 97 observational studies indexed under Cytomegalovirus Infections.
Browse Cytomegalovirus Infections studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cohort 1 will include 450 patients at the time of transplantation:
Kidney: 6 groups : 50 R+ATG no mTORi, 30 R+ATG mTORi, 50 R+ no ATG no mTORi, 30 R+ no ATG mTORi, 50 D+R- no mTORi, 30 D+R- mTORi Lung: 3 groups of 20 patients R+ ATG,R+ no ATG, D+R- Heart: 3 groups of 30 patients R+ ATG, R+ no ATG, D+R- Liver: 3 groups of 20 patients R+ ATG, R+ no ATG, D+R-
Cohort 2 will include 150 patients at the time of the infection:
Approximatively 75 patients are expected to roll-over from the cohort of solid-organ transplant recipients included at day 0 of transplantation (cohort 1).
Additional 75 patients developing a CMV infection will be also included.
A cohort 1 of solid-organ transplant recipients at day 0 of transplantation will be included:
Consecutive patients meeting the following inclusion criteria will be included:
Exclusion criteria would be:
A cohort 2 of solid-organ transplant recipients at day 0 of infection:
Consecutive patients meeting the following inclusion criteria will be included:
Exclusion criteria would be:
This cohort will include 450 patients at the time of transplantation. The following number of participants will be enrolled in the cohort according to strata defined by organ-transplanted type and baseline immune status.
This cohort will include 150 patients at the time of the infection: Approximatively 75 patients will be drawn from the cohort of solid-organ transplant recipients included at day 0 of transplantation. Additional 75 patients developing a CMV infection will be also included.
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : total volume
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies.
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : date of extraction
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 1 : day 0 of transplantation
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Time frame: from day of graft (inclusion day) to month 24
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : date of collection, date of pre-analytical processing.
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : total volume
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : number of aliquots for each biological sample: plasma, serum, whole blood, PBMC, biopsies,
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : date of extraction,
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : total volume and concentration of DNA and RNA
Time frame: from day of infection (inclusion day) to month 12
Biobank inventory for cohort 2 : day 0 of infection
Biobank inventory will be caracterise thanks to : concentration of DNA and RNA
Time frame: from day of infection (inclusion day) to month 12
Creation of a Clinical Database
Implementation of a centralized data base with clinical and sociodemographic data from all European clinical sites.
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal clinical profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal viral profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (CMV persistence)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (relapse)
Time frame: From inclusion day to month 36
Caracterised the solid organ transplants after transplantation
Assessing the longitudinal immunological profile of solid organ transplants after transplantation with or without a "difficult-to-treat" (antiviral drug resistance)
Time frame: From inclusion day to month 36
CMV caracterisation
Defining signatures combining virological data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Time frame: From inclusion day to month 36
CMV caracterisation
Defining signatures combining clinical data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Time frame: From inclusion day to month 36
CMV caracterisation
Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Time frame: From inclusion day to month 36
CMV caracterisation
Defining signatures combining immune profile of CMV-specific immunity to identify patients at risk of developing CMV infection.
Time frame: From inclusion day to month 36
CMV infection caracterisation
Defining signatures combining virological data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining clinical data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining donor/recipient data profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Time frame: From day of infection (inclusion day) to month 36
CMV infection caracterisation
Defining signatures combining immune profile of CMV-specific immunity to identify at day 0 of infection, patient at risk of developing difficult-to-treat CMV infection.
Time frame: From day of infection (inclusion day) to month 36
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux