Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients
This study, called ReCySOHT, is looking back at the medical records of adults who have had a solid organ transplant (like a kidney or heart transplant) or a blood stem cell transplant. We're focusing on patients who developed a Cytomegalovirus (CMV) infection that didn't respond well to ganciclovir, a standard medicine. Doctors want to understand why some people get this type of CMV infection and what factors might increase their risk. By looking at information from many patients, the study hopes to find common patterns. The goal is to help healthcare teams better prevent and treat these challenging CMV infections, ultimately improving care for transplant recipients.
At a glance
What is this study about?
When you have an organ transplant or a stem cell transplant, your immune system is often weaker to prevent your body from rejecting the new organ or cells. This can make you more vulnerable to infections, like Cytomegalovirus, or CMV. CMV is a common virus that can cause serious problems for transplant patients.
Usually, doctors use a medicine called ganciclovir to treat or prevent CMV infections. It's generally very effective and safe. However, sometimes the CMV infection doesn't respond to ganciclovir, either because the virus becomes resistant to the drug, or it just doesn't clear up. This is called ganciclovir-resistant or refractory (GCV-RR) CMV, and it can be a serious problem because there are fewer treatment options, and they can have more side effects. It's important for doctors to understand why this happens and who might be at higher risk.
This study is looking back at information from many transplant patients to gather more details about these specific CMV infections. By carefully reviewing existing medical records, researchers hope to identify common factors or situations that lead to ganciclovir-resistant CMV. This knowledge will be crucial for developing better ways to prevent these difficult infections and improve treatment strategies for patients in the future.
Key takeaways
- Study examines past medical records of transplant patients.
- Focuses on a difficult-to-treat CMV infection (ganciclovir-resistant).
- Aims to find risk factors for this type of infection.
- No new treatments or tests for participants.
- Information gained could improve future patient care.
- Your data will be anonymous and confidential.
Who may be eligible?
To be included in this study, you would be an adult, aged 18 or older, who has received either a solid organ transplant (like a kidney, heart, or liver) or a blood (stem cell) transplant. You would also have experienced a CMV infection that was treated with specific medicines called ganciclovir or valganciclovir.
Because this is a study looking at past medical records, researchers need to be able to find certain information in your charts. For example, they need to know details about your transplant, like if there was a good match between your body and the donor, and how you recovered after both your CMV infection and your transplant.
You wouldn't be part of this study if some of this important medical information is missing from your records, as researchers wouldn't be able to get a complete picture of your situation. For instance, if they can't find clear notes about your CMV infection, details about the donor match, or how you were doing 30, 60, or 90 days after your CMV was diagnosed, then you wouldn't be included.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you had an organ or stem cell transplant?
- Did you get a CMV infection after your transplant?
- Was your CMV infection treated with ganciclovir or valganciclovir?
- Are your medical records complete regarding your transplant and CMV treatment?
What does participation involve?
This study is a bit different because it's a "retrospective observational study." This means researchers are looking back at information that has already been collected in your past medical records. You won't need to attend any extra appointments, take new medicines, or undergo any additional tests. Your participation simply involves allowing the research team to review your existing health information to help them learn more about CMV infections in transplant patients. There are no direct visits or follow-up actions required from you.
Potential risks and benefits
Locations (23)
- MD Anderson Cancer CenterVerified postcodeHouston, United States· Not yet recruiting
- Institut Jules BordetVerified postcodeBrussels, Belgium· Not yet recruiting
- University Hospitals LeuvenVerified postcodeLeuven, Belgium· Not yet recruiting
- Helsinki University Central HospitalVerified postcodeHelsinki, Finland· Not yet recruiting
- Centre Hospitalier Universitaire de LimogesVerified postcodeLimoges, France· Not yet recruiting
- IRCCS Azienda Ospedaliero-Universitaria di BolognaVerified postcodeBologna, Italy· Recruiting
- Humanitas Research HospitalVerified postcodeRozzano, Italy· Not yet recruiting
- Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)Verified postcodePalermo, Italy· Recruiting
- Ospedale San MartinoVerified postcodeGenova, Italy· Not yet recruiting
- Policlinico di MilanoVerified postcodeMilan, Italy· Recruiting
- Azienda Ospedaliero-Universitaria di ModenaVerified postcodeModena, Italy· Recruiting
- Azienda Ospedaliera dei ColliVerified postcodeNaples, Italy· Not yet recruiting
Common questions
What is CMV and why is it important for transplant patients?
CMV is a common virus that can cause serious illness in people with weakened immune systems, such as those who have received an organ or stem cell transplant.
What does 'ganciclovir-resistant' mean?
It means the CMV infection didn't respond well to ganciclovir, a standard medicine usually used to treat it, making the infection harder to clear.
Will this study affect my current medical care?
No, this study only looks at past medical records. It will not change your current or future medical care in any way.
Is my personal information kept private?
Yes, all data collected for the study will be treated confidentially, and your personal details will be anonymised to protect your privacy.
Who is conducting this study?
The ReCySOHT study is being conducted by multiple medical centres, aiming to gather a broad range of information on CMV infections.
How to find out more
Renato Pascale, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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