RecruitingNCT05234723

Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients

Epidemiological Burden of and Risk Factors for Ganciclovir Resistant/Refractory Cytomegalovirus in Solid Organ Transplant and Hematopoietic Stem Cell Transplant Patients: Multicentre Cohort Study


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

100 participants

Start Date

Jun 19, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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

Exclusion Criteria4

  • 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

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Locations(23)

MD Anderson Cancer Center

Houston, Texas, United States

Institut Jules Bordet

Brussels, Belgium

University Hospitals Leuven

Leuven, Belgium

Helsinki University Central Hospital

Helsinki, Helsinki, Finland

Centre Hospitalier Universitaire de Limoges

Limoges, Limoges, France

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Humanitas Research Hospital

Rozzano, Milano, Italy

Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)

Palermo, Palermo, Italy

Ospedale San Martino

Genova, Italy

Policlinico di Milano

Milan, Italy

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

Azienda Ospedaliera dei Colli

Naples, Italy

Azienda Ospedale-Università Padova

Padova, Italy

AOU Città della salute e della scienza

Torino, Italy

ASST dei Sette Laghi

Varese, Italy

São João University Hospital

Porto, Portugal

Hospital Clinic

Barcelona, Spain

Instituto Maimónides de Investigación Biomédica de Córdoba

Córdoba, Spain

Gregorio Marañón General University Hospital

Madrid, Spain

University Hospital 12 de Octubre

Madrid, Spain

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Lausanne, Switzerland

University Hospital Zurich

Zurich, Switzerland

Manchester University NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05234723


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