A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe \[EU\] and Canada \[CAN\]). Data will be collected retrospectively from medical charts.

No study medicines will be provided to participants in this study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

NCT05576805

Cytomegalovirus (CMV)

COMPLETED

Reactivation of CMV Infection in Immunocompetent Patients Under Severe Stress

NCT01397058

Cytomegalovirus Viraemia Stress, Physiological Receptor, Hormonal; Disorder +1 more

UNKNOWN

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

NCT06615921

Cytomegalovirus (CMV)

COMPLETED

AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients

NCT04690933

Hematopoietic Stem Cell Transplantation Cytomegalovirus Infections Antivirals +1 more

COMPLETED

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

NCT02370758

Cytomegalovirus Viraemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an HSCT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an HSCT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytomegalovirus (CMV)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Resistant, Refractory, or Intolerant (RRI) to Anti-CMV treatment

Participants who had a HSCT after January 1, 2016, and developed post-transplant CMV infection were subsequently characterized as RRI to currently available anti-CMV treatment for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.

No interventions assigned to this group

Cohort 2: Pre-emptive CMV Treatment

Participants who had a HSCT after January 1, 2019, were preemptively treated for CMV for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

(Cohort 1) Resistant / Refractory or Intolerant:

* Aged greater than and equal to (\>=) 18 years at the time of the HSCT.
* Received an HSCT after January 1, 2016.
* Diagnosed with CMV infection any time after the HSCT date.
* Required \>=1 anti-CMV agent to manage CMV infection and were subsequently considered:

1. resistant to currently available anti-CMV agent; OR
2. refractory to currently available anti-CMV agent; OR
3. intolerant to currently available anti-CMV agent.
* Follow-up information is available for at least 12 months from the index date (i.e., date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.
* Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by Institutional Ethical Committee \[IEC\]).

(Cohort 2) Pre-emptive treatment for CMV viremia:

* Aged \>=18 years at the time of the HSCT.
* Received an HSCT after January 1, 2019.
* Diagnosed with CMV viremia any time after the HSCT date and received pre-emptive anti-CMV agent.
* Follow-up information is available for at least 12 months from the index date (i.e., date when the patient was first preemptively treated with an anti-CMV agent) or death, whichever occurs first.
* Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by IEC).

Exclusion Criteria

* Diagnosed as being positive for human immunodeficiency virus before the HSCT.
* Unable to demonstrate a minimum of 12 months of follow-up from the index date (e.g., incomplete information on dates showing follow-up time).
* Participation in a clinical trial related to CMV treatment during the study period.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No