NCT05234723 Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients
| NCT ID | NCT05234723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Cytomegalovirus Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-06-19 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Renato Pascale, MD
PRINCIPAL INVESTIGATOR
IRCCS AOUBO
Frequently Asked Questions
Who can join the NCT05234723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytomegalovirus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05234723 currently recruiting?
Yes, NCT05234723 is actively recruiting participants. Contact the research team at renato.pascale@aosp.bo.it for enrollment information.
Where is the NCT05234723 trial being conducted?
This trial is being conducted at Houston, United States, Brussels, Belgium, Leuven, Belgium, Helsinki, Finland and 11 additional locations.
Who is sponsoring the NCT05234723 clinical trial?
NCT05234723 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Renato Pascale, MD at IRCCS AOUBO. The trial plans to enroll 100 participants.