A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Hematopoietic Stem Cell Transplant (HSCT) Recipients in Europe and Canada (OTUS HSCT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Netherlands, Poland and Serbia)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 11
- 主要终点
- Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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,
- •Diagnosed with CMV infection any time after the HSCT date.
- •Required >=1 anti-CMV agent to manage CMV infection and were subsequently considered:
- •resistant to currently available anti-CMV agent; OR
- •refractory to currently available anti-CMV agent; OR
- •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,
- •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 (both cohorts)
- •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.
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
时间窗: At Week 20 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With Non-Detectable CMV During the Index Episode Prior to and After the Index Date
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) OR pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites.
Percentage of Participants With Non-Detectable CMV at Week 8 After Index Date
时间窗: At Week 8 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With Non-Detectable CMV at 1-year After Index Date
时间窗: At 1-year after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Time From Start of Index Episode to CMV Viremia Clearance as Defined by Site Investigator
时间窗: From start of index episode to CMV viremia clearance (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 8 After Index Date
时间窗: At Week 8 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Time From HSCT Until Start of Asymptomatic and Symptomatic Index Episode
时间窗: From HSCT up to start date of the index episode (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic episode is an episode wherein there is "Tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes are defined as new CMV infection in a participant with previous evidence of CMV infection. Symptomatic episode is an episode wherein there is "tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index and Recurrent Episodes
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV-treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Percentage of Participants With Non-Detectable CMV at Week 20 After Index Date
时间窗: At Week 20 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Time From Treatment Initiation Until Evidence of Non-detectable CMV at the Index Episode
时间窗: Time from treatment initiation until evidence of non-detectable CMV (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at 1-year After Index Date
时间窗: At 1-year after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Time From Treatment Initiation to CMV Viremia Clearance as Defined by Site Investigator at the Index Episode
时间窗: From Treatment Initiation to CMV Viremia Clearance (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Time From Start of Index Episode to First Symptomatic CMV Diagnosis
时间窗: From start of index episode to first symptomatic CMV diagnosis (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic CMV is defined CMV-related tissue invasive disease or CMV syndrome. Time from start of index episode to first symptomatic CMV diagnosis (tissue invasive disease diagnosis) will be reported.
Percentage of Participants With Engraftment From HSCT
时间窗: Up to 7 years 3 months
Engraftment is the process by which hematopoietic stem cells (HSC) make their way (homing) to free bone marrow (BM) niches where they can find optimal conditions to survive and proliferate. Percentage of participants with engraftment from HSCT will be reported.
Number of Genetic Mutations Conferring Anti-CMV Resistance From HSCT and at Index Episode
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Number of genetic mutations conferring anti-CMV resistance from HSCT and at index date will be reported.
Time From Stop Date of the Index Episode to First Recurrent Asymptomatic and Symptomatic CMV Viremia
时间窗: From stop date of the index episode to first recurrent asymptomatic and symptomatic CMV viremia (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection.
Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Percentage of participants with anti-CMV treatment-related myelosuppression and each type nephrotoxicity overall and during the index episode will be reported.
Percentage of Participants With Graft Failure From HSCT and Index Date
时间窗: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Graft failure is defined as a serious complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT) defined as either lack of initial engraftment of donor cells (primary graft failure) or loss of donor cells after initial engraftment (secondary graft failure). Percentage of participants with graft failure (primary/secondary) from HSCT and index date will be reported.
Percentage of Participants With Graft Versus Host Disease (GvHD) From HSCT and Index Date
时间窗: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Percentage of participants with GvHD (acute, chronic) from HSCT and from the index date will be reported.
Percentage of Participants who Died due to any Cause From HSCT and Index Date
时间窗: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Percentage of participants who died due to any cause from HSCT and from the index date will be reported.
Percentage of Participants who Died due to CMV Infection From HSCT and Index Date
时间窗: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Percentage of participants who died due to CMV infection from HSCT and the index date will be reported.
Percentage of Participants With a Genetic Mutation Conferring Anti-CMV Resistance From HSCT and at Index Episode
时间窗: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Percentage of participants with a genetic mutation (i.e., UL27, UL54, UL56, UL97, other, unknown) conferring anti-CMV resistance from HSCT and at the index episode will be reported.
次要结局
- Number of Individual and Dual-therapy of Anti-CMV Agents Used During CMV Episodes(Up to 7 years 3 months)
- Number of Anti-CMV Therapies Used for Primary or Secondary Prophylaxis and Pre-emptive Treatment(Up to 7 years 3 months)
- Duration of Anti-CMV Therapy During CMV Episodes(Up to 7 years 3 months)
- Duration of Anti-CMV Prophylaxis Therapy(Up to 7 years 3 months)
- Number of Participants With Distribution of Switches of Anti-CMV Agents at the Index Date(Up to years 3 months)
- Percentage of Participants Administered With First, Second, Third and Fourth Line of Anti-CMV Treatments From HSCT(Up to 7 years 3 months)
- Percentage of Participants With Mono-therapy and Dual-therapy of Anti-CMV Agents of Interest During CMV Episodes(Up to 7 years 3 months)
- Number With Individual and Dual Therapy of Anti-CMV Agents Used by Line of Treatment During Index Episode(Up to 7 years 3 months)
- Number of Participants Using Immunosuppressant From HSCT(Up to 7 years 3 months)
- Duration of Stay in Critical Care and Non-critical Care(Up to 7 years 3 months)
- Percentage of Participants With Anti-CMV Primary or Secondary Prophylaxis and Pre-emptive Treatment(Up to 7 years 3 months)
- Time from HSCT to Administration of First-line Anti-CMV Agents of Interest and Between First-line Through the Fourth Line of Treatment(Up to 7 years 3 months)
- Number of Participants With Anti-CMV Agent Administered When Diagnosed With Myelosuppression and Nephrotoxicity(Up to 7 years 3 months)
- Number of Participants With CMV-related Outpatient Clinic Visits From HSCT and Index Date(Up to 7 years 3 months)
- Number of Participants Based on Selected Procedures Performed at Hospitalizations and Emergency Department Visits From HSCT and Index Date(Up to 7 years 3 months)
- Length of Hospital Stay for CMV-related Hospitalizations and Hospital Acquired CMV Viremia(Up to 7 years 3 months)
- Number of Participants Based on Reasons for Anti-CMV Dose Changes or Discontinuation for Anti-CMV Agents of Interest(Up to 7 years 3 months)
- Number of Participants Based on Selected Procedures Performed at Outpatient Clinical Visits From HSCT and Index Date(Up to 7 years 3 months)
- Number of Participants Based on CMV-related Hospitalizations and Emergency Department Visits From HSCT and Index Date(Up to 7 years 3 months)
- Number of Participants Categorized Based on Reasons for CMV-related Hospitalization(Up to 7 years 3 months)