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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 23 sites (Houston, Texas and 22 other locations) |
| Status | Recruiting |
| Started | June 19, 2023 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT05234723 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
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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
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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
- Principal investigator: Renato Pascale, MD — Irccs Aoubo
- Study coordinator: Renato Pascale, MD
- Email: renato.pascale@aosp.bo.it
- Phone: +390512144350
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CMV-specific T cells after CMV reactivation in adults after HSCT
This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.
-
Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
-
T-cell–guided letermovir stopping after allogeneic stem cell transplant
This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.
-
Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant
This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.
-
CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants
Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.
-
R-MVST cell therapy for viral infections in children and young adults
This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.