Clinical trial NCT05576805: A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
Official title: A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Solid Organ Transplant (SOT) Recipients in Europe and Canada (OTUS SOT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Italy, Netherlands, Poland and Sweden)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus (CMV)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-10-13
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who had a CMV infection treated with at least one anti-CMV agent and considered resistant, refractory, or intolerant to a currently available agent will be enrolled in Cohort 1 and participants who received pre-emptive therapy for CMV viremia will be enrolled in Cohort 2.

Brief summary: 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.

Detailed description: This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an SOT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an SOT 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).

Eligibility criteria: Inclusion Criteria:

(Cohort 1) Resistant / Refractory or Intolerant:

1. Aged greater than or equal to (\>=) 18 years at the time of the SOT.
2. Received an SOT after January 1, 2016.
3. Diagnosed with asymptomatic or symptomatic CMV infection any time after the SOT date.
4. 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.
5. Follow-up information is available for at least 12 months from the index date (that is, date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first.
6. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the Institutional Ethical Committee \[IEC\]).

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

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

Exclusion Criteria: (Cohorts 1 and 2)

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

Primary outcomes:
measure: Time from Solid Organ Transplant (SOT) Until Start Date of the Symptomatic or Asymptomatic Index Episode
timeFrame: From SOT up to start date of the index episode (Up to 7 years 3 months)
measure: Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index Episode and for Recurrent Episodes
timeFrame: Up to 7 years 3 months
measure: Time From Start of Index Episode to CMV Viremia Clearance as Defined by Site Investigator
timeFrame: From start of index episode to CMV viremia clearance (Up to 7 years 3 months)
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 8 After Index Date
timeFrame: At Week 8 after index date
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
timeFrame: At Week 20 after index date
measure: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at 1-year After Index Date
timeFrame: At 1-year after index date
measure: Percentage of Participants With Non-detectable CMV During the Index Episode Prior to and After the Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Evidence of Non-detectable CMV at Week 8 After Index Date
timeFrame: At Week 8 after index date
measure: Percentage of Participants With Evidence of Non-detectable CMV at Week 20 After Index Date
timeFrame: At Week 20 after index date
measure: Percentage of Participants With Evidence of Non-detectable CMV at 1-year After Index Date
timeFrame: At 1-year after index date
measure: Time From Treatment Initiation to CMV Viremia Clearance as Defined by Site Investigator at the Index Episode
timeFrame: From Treatment Initiation to CMV Viremia Clearance (Up to 7 years 3 months)
measure: Time From Treatment Initiation Until Evidence of Non-detectable CMV at the Index Episode
timeFrame: Time from treatment initiation until evidence of non-detectable CMV (Up to 7 years 3 months)
measure: Time from Start of Index Episode to First Symptomatic CMV Diagnosis
timeFrame: From start of index episode to first symptomatic CMV diagnosis (Up to 7 years 3 months)
measure: Time From Stop Date of the Index Episode to First Recurrent Asymptomatic and Symptomatic CMV Viremia
timeFrame: From stop date of the index episode to first recurrent asymptomatic and symptomatic CMV viremia (Up to 7 years 3 months)
measure: Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Organ Rejection From SOT
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Graft Loss From SOT and the Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants who Died due to any Cause From SOT and Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants who Died due to CMV Infection From SOT and Index Date
timeFrame: Up to 7 years 3 months
measure: Number of Genetic Mutations Conferring Anti-CMV Resistance From SOT and Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With a Genetic Mutation Conferring Anti-CMV Resistance From SOT at the Index Date
timeFrame: Up to 7 years 3 months
Secondary outcomes:
measure: Percentage of Participants With Anti-CMV Primary or Secondary Prophylaxis and Preemptive Treatment
timeFrame: Up to 7 years 3 months
measure: Number of Anti-CMV Therapies Used for Primary or Secondary Prophylaxis and Preemptive Treatment
timeFrame: Up to 7 years 3 months
measure: Duration of Anti-CMV Prophylaxis Therapy
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants With Mono-therapy and Dual-therapy of Anti-CMV Agents of Interest During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number of Individual and Dual-therapy of Anti-CMV Agents Used During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number With Individual and Dual Therapy of Anti-CMV Agents Used by Line of Treatment Overall and During the Index Episodes
timeFrame: Up to 7 years 3 months
measure: Duration of Anti-CMV Therapy During CMV Episodes
timeFrame: Up to 7 years 3 months
measure: Number of Participants With Distribution of Switches of Anti-CMV Agents at the Index Date
timeFrame: Up to 7 years 3 months
measure: Percentage of Participants Administered With First, Second, Third and Fourth Line of Anti-CMV Treatments From SOT
timeFrame: Up to 7 years 3 months
measure: Time From SOT to Administration of First-line Anti-CMV Agents of Interest and Between First-line Through the Fourth Line of Treatment
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on Reasons for Anti-CMV Dose Changes or Discontinuation for Anti-CMV Agents of Interest
timeFrame: Up to 7 years 3 months
measure: Number of Participants With Anti-CMV Agent Administered When Diagnosed With Myelosuppression and Nephrotoxicity
timeFrame: Up to 7 years 3 months
measure: Number of Participants Using Immunosuppressant From SOT
timeFrame: Up to 7 years 3 months
measure: Number of Participants With CMV-related Outpatient Clinic Visits From SOT and Index Date
timeFrame: From SOT and index date up to 7 years 3 months
measure: Number of Participants Based on Selected Procedures Performed at Outpatient Clinical Visits From SOT and Index Date
timeFrame: From SOT and index date up to 7 years 3 months
measure: Number of Participants Based on CMV-related Hospitalizations and Emergency Department Visits From SOT and Index Date
timeFrame: From SOT and index date up to 7 years 3 months
measure: Number of Participants Categorized Based on Reasons for CMV-related Hospitalization
timeFrame: Up to 7 years 3 months
measure: Number of Participants Based on Selected Procedures Performed at Hospitalizations and Emergency Department Visits From SOT and Index Date
timeFrame: From SOT and index date up to 7 years 3 months
measure: Length of Hospital Stay for CMV-related Hospitalizations and Hospital Acquired CMV Viremia
timeFrame: Up to 7 years 3 months
measure: Duration of Stay in Critical Care and Non-critical Care
timeFrame: Up to 7 years 3 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MU Graz
city: Innsbruck
country: Austria
facility: MU Innsbruck
city: Leuven
country: Belgium
facility: UZ Leuven
city: Vancouver
country: Canada
facility: Vancouver GH (VCH)
state: British Columbia
city: Thessaloniki
country: Greece
facility: Aristotle USM
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Parma
country: Italy
facility: U Parma
city: Roma
country: Italy
facility: FP Vergata
city: Varese
country: Italy
facility: U Insubria
city: Rotterdam
country: Netherlands
facility: Erasmus UMC
city: Utrecht
country: Netherlands
facility: UMC Utrech
city: Gdańsk
country: Poland
facility: UCC Gdansk
city: Warszawa
country: Poland
facility: MU Warsaw
city: Solna
country: Sweden
facility: Karolinska UH
city: Uppsala
country: Sweden
facility: Uppsala UH
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: