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Transplant patients at risk of Drug-Resistant virus under microscope

NCT ID NCT05234723

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is looking at 100 adult patients who have had an organ or stem cell transplant and later developed a CMV infection that is resistant or hard to treat with standard antiviral drugs. Researchers want to find out how common this problem is and what factors make it more likely. The goal is to use this information to design better ways to prevent and manage these tough infections in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors identify which transplant patients are at highest risk for drug-resistant CMV, leading to better prevention and treatment strategies.
What could go wrong
This is an observational study, not a treatment trial. It will not directly test any new drug or therapy, and results may not lead to immediate changes in patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All adult (≥ 18 years) patients who underwent SOT or HSCT developing CMV-infection treated with GC/VGC during the study period will be screened for inclusion according to inclusion and exclusion criteria. Eligible patients will be classified as cases or controls according to the following definitions: * Case: SOT or HSCT recipients with genotypically confirmed GCV-RR CMV-event; * Control: SOT or HSCT recipients with "presumed" GCV-S CMV-event on the basis of good microbiological and clinical response to standard GCV/VGC treatment.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cytomegalovirus infection Multiple Acyl Coenzyme A Dehydrogenase Deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cytomegalovirus infections

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Città della salute e della scienza

    RECRUITING

    Torino, 10126, Italy

  • ASST dei Sette Laghi

    NOT_YET_RECRUITING

    Varese, 21100, Italy

  • Azienda Ospedale-Università Padova

    NOT_YET_RECRUITING

    Padova, 35128, Italy

  • Azienda Ospedaliera dei Colli

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero-Universitaria di Modena

    RECRUITING

    Modena, 41125, Italy

  • Centre Hospitalier Universitaire de Limoges

    NOT_YET_RECRUITING

    Limoges, Limoges, 87000, France

  • Centre hospitalier universitaire vaudois (CHUV)

    NOT_YET_RECRUITING

    Lausanne, Lausanne, 1011, Switzerland

  • Gregorio Marañón General University Hospital

    NOT_YET_RECRUITING

    Madrid, 28007, Spain

  • Helsinki University Central Hospital

    NOT_YET_RECRUITING

    Helsinki, Helsinki, 00290, Finland

  • Hospital Clinic

    RECRUITING

    Barcelona, 08036, Spain

  • Humanitas Research Hospital

    NOT_YET_RECRUITING

    Rozzano, Milano, 20089, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy

  • Institut Jules Bordet

    NOT_YET_RECRUITING

    Brussels, 1070, Belgium

  • Instituto Maimónides de Investigación Biomédica de Córdoba

    RECRUITING

    Córdoba, 14004, Spain

  • Istituto mediterraneo per i trapianti e terapie ad alta specializzazione (ISMETT)

    RECRUITING

    Palermo, Palermo, 90127, Italy

  • MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030-4009, United States

  • Manchester University NHS Foundation Trust

    NOT_YET_RECRUITING

    Manchester, United Kingdom

  • Ospedale San Martino

    NOT_YET_RECRUITING

    Genova, 16132, Italy

  • Policlinico di Milano

    RECRUITING

    Milan, 20122, Italy

  • São João University Hospital

    NOT_YET_RECRUITING

    Porto, 4200-319, Portugal

  • University Hospital 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, 28026, Spain

  • University Hospital Zurich

    NOT_YET_RECRUITING

    Zurich, 8091, Switzerland

  • University Hospitals Leuven

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

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