Comparing methods to monitor HCMV infections in transplant patients on letermovir
Comparison of Two Strategies for Monitoring HCMV Breakthrough Infections During Letermovir Prophylaxis. a Multicenter, Randomized, Open-label Trial
This study is testing two ways to check for HCMV infections in transplant patients taking letermovir to see which method helps avoid unnecessary antiviral treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | prednisone |
| Locations | 8 sites (Brescia, BS and 7 other locations) |
| Trial ID | NCT06339892 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate two different strategies for monitoring human cytomegalovirus (HCMV) infections in patients who have undergone hematopoietic stem cell transplantation and are receiving letermovir (LTV) as prophylaxis. The study will compare the detection of HCMV DNA in blood with and without prior digestion of non-infectious DNA using DNAse. Patients will be randomized into two groups: one will undergo standard testing without DNAse treatment, while the other will have DNAse treatment to differentiate between infectious and non-infectious HCMV DNA. The goal is to reduce unnecessary antiviral drug use and associated side effects by accurately identifying productive infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing allogeneic hematopoietic stem cell transplantation and are HCMV IgG seropositive prior to the transplant.
Not a fit: Patients under 18 years old or those unable to comply with the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective monitoring of HCMV infections, reducing the need for unnecessary antiviral treatments and their side effects.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving monitoring strategies for viral infections in transplant patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age\>18 years. * Allogeneic hematopoietic stem cell transplant. * HCMV IgG seropositivity before transplant * Written informed consent. * LTV prophylaxis administration Exclusion Criteria: * Age \<18 years. * Inability to comply with the requirements of the protocol.
Where this trial is running
Brescia, BS and 7 other locations
- ASST-Spedali Civili — Brescia, Bs, Italy (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pv, Italy (Recruiting)
- ASST-Ospedale Papa Giovanni XXIII — Bergamo, Italy (Not_yet_recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Not_yet_recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milano, Italy (Not_yet_recruiting)
- Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" — Reggio Calabria, Italy (Not_yet_recruiting)
- AOU Policlinico Umberto I — Roma, Italy (Not_yet_recruiting)
- Policlinico Universitario Agostino Gemelli — Roma, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Fausto Baldanti, MD — Fondazione IRCCS Policlinico San Matteo
- Study coordinator: Daniele Lilleri, MD
- Email: d.lilleri@smatteo.pv.it
- Phone: +39 0382 502420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.