NCT05234723

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
9 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2023Feb 2028

First Submitted

Initial submission to the registry

January 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 19, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

3.7 years

First QC Date

January 9, 2022

Last Update Submit

June 11, 2026

Conditions

Cytomegalovirus Infections

Keywords

Ganciclovir-resistant CMVCytomegalovirusSolid Organ TransplantGanciclovirGanciclovir-refractory CMVHematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (2)

  • To define incidence of GCV-RR CMV-infection in SOT and HSCT patients

    To define incidence of GCV-RR CMV-infection in SOT and HSCT patients

    Through study completion, an average of 1 year

  • To define the risk factors for GCV-RR CMV-infection development in SOT and HSCT patients

    To define the risk factors for GCV-RR CMV-infection development in SOT and HSCT patients

    Through study completion, an average of 1 year

Secondary Outcomes (8)

  • To compare type of CMV episode between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection

    Through study completion, an average of 1 year

  • To compare virological cure between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection

    Through study completion, an average of 1 year

  • To compare clinical cure between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection

    Through study completion, an average of 1 year

  • To compare graft outcome between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection

    Through study completion, an average of 1 year

  • To compare the need of ICU and hospital stay between SOT and HSCT patients with GCV-RR versus GCV-S CMV-infection

    Through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (1)

Solid Organ Transplant and Hematopoietic Stem Cell Transplant patients

Solid Organ Transplant (SOT) and Hematopoietic Stem Cell Transplant (HSCT) patients with Ganciclovir Resistant or Refractory Cytomegalovirus infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

NOT YET RECRUITING

Institut Jules Bordet

Brussels, 1070, Belgium

NOT YET RECRUITING

University Hospitals Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Helsinki University Central Hospital

Helsinki, Helsinki, 00290, Finland

NOT YET RECRUITING

Centre Hospitalier Universitaire de Limoges

Limoges, Limoges, 87000, France

NOT YET RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

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

Palermo, Palermo, 90127, Italy

RECRUITING

Ospedale San Martino

Genova, 16132, Italy

NOT YET RECRUITING

Policlinico di Milano

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, 41125, Italy

RECRUITING

Azienda Ospedaliera dei Colli

Naples, 80131, Italy

NOT YET RECRUITING

Azienda Ospedale-Università Padova

Padova, 35128, Italy

NOT YET RECRUITING

AOU Città della salute e della scienza

Torino, 10126, Italy

RECRUITING

ASST dei Sette Laghi

Varese, 21100, Italy

NOT YET RECRUITING

São João University Hospital

Porto, 4200-319, Portugal

NOT YET RECRUITING

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

Instituto Maimónides de Investigación Biomédica de Córdoba

Córdoba, 14004, Spain

RECRUITING

Gregorio Marañón General University Hospital

Madrid, 28007, Spain

NOT YET RECRUITING

University Hospital 12 de Octubre

Madrid, 28026, Spain

NOT YET RECRUITING

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Lausanne, 1011, Switzerland

NOT YET RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Manchester University NHS Foundation Trust

Manchester, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Cytomegalovirus InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Study Officials

  • Renato Pascale, MD

    IRCCS AOUBO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renato Pascale, MD

CONTACT

+390512144350renato.pascale@aosp.bo.it

Maddalena Giannella, MD, PhD

CONTACT

+390512143199maddalena.giannella@unibo.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2022

First Posted

February 10, 2022

Study Start

June 19, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations

ES(4)GB(1)IT(10)FR(1)BE(2)CH(2)PT(1)FI(1)US(1)