Clinical trial Recruiting at 7 sites Observational Ages 18 and up

Ganciclovir-Resistant Cytomegalovirus in Organ and Stem Cell Transplants

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT05234723 · Data updated 2026-11-12

This study tests how often and why ganciclovir-resistant CMV occurs in adults after solid organ or hematopoietic stem cell transplants.

More Cytomegalovirus Infections trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Locations23 sites (Houston, Texas and 22 other locations)
StatusRecruiting
StartedJune 19, 2023
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2028
Registry record updatedJune 15, 2026
Trial IDNCT05234723 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) who have undergone SOT or HSCT and developed CMV infection treated with ganciclovir.

Probably not a fit

Patients without CMV infection or those not treated with ganciclovir would not directly benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ReCySOHT study is a multicenter, retrospective, observational case-control analysis. It aims to identify risk factors and incidence of ganciclovir-resistant or refractory CMV infection in SOT and HSCT patients. By examining past cases and controls, the study seeks to inform future prevention and management strategies for this difficult CMV complication. The research will rely on existing clinical and laboratory data to characterize patterns related to treatment resistance. Interventions are not specified within the study design.

Why it matters

Potential benefit: Understanding risk factors could guide prevention and improve management of GCV-RR CMV in transplant recipients.

How similar studies have gone: Prior experience has shown variability in resistance rates; this study builds on observational data to better define risks in this population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Bologna, Italy
    Recruiting
  • Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)
    Palermo, Palermo, Italy
    Recruiting
  • Policlinico di Milano
    Milan, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria di Modena
    Modena, Italy
    Recruiting
  • AOU Città della salute e della scienza
    Torino, Italy
    Recruiting
  • Hospital Clinic
    Barcelona, Spain
    Recruiting
Show 17 more locations
  • Instituto Maimónides de Investigación Biomédica de Córdoba
    Córdoba, Spain
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Not yet recruiting
  • Institut Jules Bordet
    Brussels, Belgium
    Not yet recruiting
  • University Hospitals Leuven
    Leuven, Belgium
    Not yet recruiting
  • Helsinki University Central Hospital
    Helsinki, Helsinki, Finland
    Not yet recruiting
  • Centre Hospitalier Universitaire de Limoges
    Limoges, Limoges, France
    Not yet recruiting
  • Humanitas Research Hospital
    Rozzano, Milano, Italy
    Not yet recruiting
  • Ospedale San Martino
    Genova, Italy
    Not yet recruiting
  • Azienda Ospedaliera dei Colli
    Naples, Italy
    Not yet recruiting
  • Azienda Ospedale-Università Padova
    Padova, Italy
    Not yet recruiting
  • ASST dei Sette Laghi
    Varese, Italy
    Not yet recruiting
  • São João University Hospital
    Porto, Portugal
    Not yet recruiting
  • Gregorio Marañón General University Hospital
    Madrid, Spain
    Not yet recruiting
  • University Hospital 12 de Octubre
    Madrid, Spain
    Not yet recruiting
  • Centre hospitalier universitaire vaudois (CHUV)
    Lausanne, Lausanne, Switzerland
    Not yet recruiting
  • University Hospital Zurich
    Zurich, Switzerland
    Not yet recruiting
  • Manchester University NHS Foundation Trust
    Manchester, United Kingdom
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.