Understanding Cytomegalovirus Interactions in Organ Transplant Patients

Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation

This study is trying to learn how Cytomegalovirus affects the immune system in organ transplant patients to find ways to reduce infections and the need for harsh treatments.

Quick facts

• Study type: Observational
• Enrollment: 525 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (other)
• Locations: 7 sites (Bordeaux and 6 other locations)
• Trial ID: NCT05701228 on ClinicalTrials.gov

What this trial studies

The HORUS project aims to improve our understanding of how Cytomegalovirus (CMV) interacts with the immune system of solid organ transplant recipients. By establishing a European cohort of patients, the study will collect clinical data and biological samples to analyze immune responses, viral characteristics, and the effects of immunosuppressive drugs. This observational study seeks to identify risk factors and clinical outcomes associated with CMV infections, ultimately aiming to reduce the incidence of CMV disease and the need for toxic antiviral therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are receiving solid organ transplants, such as kidneys, lungs, livers, or hearts.

Not a fit: Patients who are unable or unwilling to comply with study procedures or those who are legally detained in an official institution may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of CMV infections in organ transplant patients, enhancing their overall health and reducing complications.

How similar studies have performed: While the specific approach of this study is novel, previous studies have shown the importance of understanding host-virus interactions in improving outcomes for transplant patients.

Eligibility criteria

A cohort 1 of solid-organ transplant recipients at day 0 of transplantation will be included:

* Consecutive patients meeting the following inclusion criteria will be included:

  * Men and women,
  * Age \>= 18 years receiving a (living or deceased donor) kidney, lung, liver, and heart allograft,
  * written informed consent obtained from subject,
  * ability to understand and give their written consent,
  * affiliated to health insurance.
* Exclusion criteria would be:

  * D-R- recipients,
  * participant unable or unwilling to comply with study procedures,
  * subjects who are legally detained in an official institution.

A cohort 2 of solid-organ transplant recipients at day 0 of infection:

* Consecutive patients meeting the following inclusion criteria will be included:

  * Men and women,
  * Age \>= 18 years receiving a (living or deceased donor) kidney, lung, liver, and heart allograft
  * written informed consent obtained from subject,
  * ability to understand and give their written consent,
  * affiliated to health insurance,
  * post-transplant CMV infection episode.
* Exclusion criteria would be:

  * D-R- recipients,
  * participant unable or unwilling to comply with study procedures,
  * subjects who are legally detained in an official institution.

Where this trial is running

Bordeaux and 6 other locations

• Hopitel Pellegrin — Bordeaux, France (RECRUITING)
• Hôpital Edouard Hériot — Lyon, France (RECRUITING)
• Hôpital LA PITIE SALPETRIERE — Paris, France (RECRUITING)
• Hôpital Necker — Paris, France (RECRUITING)
• Hôpital Foch — Suresnes, France (RECRUITING)
• Hôpital Rangueil — Toulouse, France (RECRUITING)
• Hôpital Paul Brousse — Villejuif, France (RECRUITING)

Study contacts

• Study coordinator: Hannah KAMINSKI, Pr

Conditions: Cytomegalovirus Infections, Solid Organ Transplantation, immunocompromised hosts, immune response