NCT05234723 · IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients
(ReCySOHT)
What this study is about
The ReCySOHT study is a conducted at multiple hospitals, reviewing past data, 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).
View original scientific description
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.
Primary outcome measures
To define incidence of GCV-RR CMV-infection in SOT and HSCT patients
Time frame: Through study completion, an average of 1 year
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
Time frame: Through study completion, an average of 1 year
To define the risk factors for GCV-RR CMV-infection development in SOT and HSCT patients
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations