Epidemiological Burden of and Risk Factors for Ganciclovir Resistant/Refractory Cytomegalovirus in Solid Organ Transplant and Hematopoietic Stem Cell Transplant Patients: Multicentre Cohort Study
Status: Recruiting
Location: See all (23) locations...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Other Locations
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Brussels
University Hospitals Leuven
NOT_YET_RECRUITING
Leuven
Finland
Helsinki University Central Hospital
NOT_YET_RECRUITING
Helsinki
France
Centre Hospitalier Universitaire de Limoges
NOT_YET_RECRUITING
Limoges
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Ospedale San Martino
NOT_YET_RECRUITING
Genova
Policlinico di Milano
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena
RECRUITING
Modena
Azienda Ospedaliera dei Colli
NOT_YET_RECRUITING
Naples
Azienda Ospedale-Università Padova
NOT_YET_RECRUITING
Padova
Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)
RECRUITING
Palermo
Humanitas Research Hospital
NOT_YET_RECRUITING
Rozzano
AOU Città della salute e della scienza
RECRUITING
Torino
ASST dei Sette Laghi
NOT_YET_RECRUITING
Varese
Portugal
São João University Hospital
NOT_YET_RECRUITING
Porto
Spain
Hospital Clinic
RECRUITING
Barcelona
Instituto Maimónides de Investigación Biomédica de Córdoba
RECRUITING
Córdoba
Gregorio Marañón General University Hospital
NOT_YET_RECRUITING
Madrid
University Hospital 12 de Octubre
NOT_YET_RECRUITING
Madrid
Switzerland
Centre hospitalier universitaire vaudois (CHUV)
NOT_YET_RECRUITING
Lausanne
University Hospital Zurich
NOT_YET_RECRUITING
Zurich
United Kingdom
Manchester University NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Renato Pascale, MD
renato.pascale@aosp.bo.it
+390512144350
Backup
Maddalena Giannella, MD, PhD
maddalena.giannella@unibo.it
+390512143199
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 100
Treatments
Solid Organ Transplant and Hematopoietic Stem Cell Transplant patients
Solid Organ Transplant (SOT) and Hematopoietic Stem Cell Transplant (HSCT) patients with Ganciclovir Resistant or Refractory Cytomegalovirus infection
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna