The ReCySOHT study is a multicenter, retrospective, observational case-control study on the risk factors for developing a ganciclovir-resistant/refractory (GCV-RR) cytomegalovirus infection in patients receiving solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT). Aims of the study are to investigate the incidence of and risk factors for GCV-RR CMV infection in SOT recipients and HSCT patients in order to design further studies aimed at preventing and improving the patient management of GCV-RR CMV infections.
All adult (≥ 18 years) patients who underwent SOT or HSCT developing CMV-infection treated with GC/VGC
Ability to understand the purpose of the study and provide signed and dated informed consent
Lack of clinical and/or laboratory data regarding the type of CMV event
Lack of the serological mismatch at transplantation
Lack of the type of SOT or HSCT
Lack of the patient and graft outcome at 30, 60 or 90 days after CMV event diagnosis
All adult (≥ 18 years) patients who underwent SOT or HSCT developing CMV-infection treated with GC/VGC during the study period will be screened for inclusion according to inclusion and exclusion criteria. Eligible patients will be classified as cases or controls according to the following definitions: * Case: SOT or HSCT recipients with genotypically confirmed GCV-RR CMV-event; * Control: SOT or HSCT recipients with "presumed" GCV-S CMV-event on the basis of good microbiological and clinical response to standard GCV/VGC treatment.
Case-control
Retrospective
Not listed
To define incidence of GCV-RR CMV-infection in SOT and HSCT patients
To define incidence of GCV-RR CMV-infection in SOT and HSCT patients
To define the risk factors for GCV-RR CMV-infection development in SOT and HSCT patients
To define the risk factors for GCV-RR CMV-infection development in SOT and HSCT patients
To compare type of CMV episode between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare type of CMV episode: infection or disease (the last cathegorized as CMV syndrome or Tissue invasion) between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare virological cure between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare virological cure at 30, 60 and 90 days after CMV infection diagnosis and relapse of CMV infection between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare clinical cure between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare clinical cure at 30, 60 and 90 days after CMV infection diagnosis between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare graft outcome between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
To compare graft failure rate and the need of re-transplant between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection
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