Cytomegalovirus (CMV) in allogeneic hematopoietic stem cell transplant patients

Multinational CMV Outcomes, Treatment Patterns and Healthcare Resource Utilization Study following Hematopoietic Stem Cell Transplant (OTUS HSCT)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN78128786

Enrollment

400

Registered

2021-11-25

Start date

2020-10-16

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus infection in transplanted patients Infections and Infestations

Interventions

The study will use the healthcare information that has already been documented from 1 January 2014 (until no later than determined at site level) related to the HSCT, CMV infections and outcomes inclu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cohort 1: Resistant/refractory/intolerant inclusion criteria: 1. Aged =18 years at the time of the HSCT 2. Received an HSCT after 1 January 2014 3. Diagnosed with CMV infection any time after the HSCT date 4. Characterized as resistant to currently available treatments, OR refractory to currently available treatments, OR considered intolerant to currently available treatments 5. Follow-up data are available for at least 12 months (1 year) after being characterized in item (4) (above) or until death, whichever occurs first Cohort 2: Pre-emptive treatment for CMV viremia inclusion criteria: 1. Aged =18 years at the time of the HSCT 2. Received an HSCT after 1 January 2017 3. Diagnosed with CMV viremia any time after the HSCT date 4. Received pre-emptive treatment 5. Follow-up data are available for at least 12 months (1 year) after being characterized in item (4) (above) or until death, whichever occurs first

Exclusion criteria

Exclusion criteria: Positive test for HIV before the HSCT

Design outcomes

Primary

Measure	Time frame
1. Number of CMV viremia episodes measured using patient records from transplant date until the end of follow-up 2. Time from HSCT to CMV viremia measured using patient records 3. Time to CMV viremia clearance measured using patient records 4. Incidence and time to CMV recurrence measured using patient records from CMV index episode until the end of follow-up 5. Incidence of tissue invasive disease measured using patient records from transplant date until the end of follow-up 6. Incidence of graft rejection measured using patient records from transplant date until the end of follow-up 7. Incidence of post-HSCT non-CMV infections requiring intravenous (IV) treatment or hospitalization, measured using patient records from transplant date to 365 days following the last PRRI CMV episode or until death (whichever occurs first) 8. Incidence of anti-CMV treatment-related myelosuppression, nephrotoxicity or other toxicities, measured using patient records from the first CMV episode until the end of follow-up 9. CMV resistance measured using patient records from the first CMV episode until the end of follow-up 10. CMV-associated mortality measured using patient records 11. All-cause mortality measured using patient records *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first.	—

Measure

Time frame

1. Number of CMV viremia episodes measured using patient records from transplant date until the end of follow-up 2. Time from HSCT to CMV viremia measured using patient records 3. Time to CMV viremia clearance measured using patient records 4. Incidence and time to CMV recurrence measured using patient records from CMV index episode until the end of follow-up 5. Incidence of tissue invasive disease measured using patient records from transplant date until the end of follow-up 6. Incidence of graft rejection measured using patient records from transplant date until the end of follow-up 7. Incidence of post-HSCT non-CMV infections requiring intravenous (IV) treatment or hospitalization, measured using patient records from transplant date to 365 days following the last PRRI CMV episode or until death (whichever occurs first) 8. Incidence of anti-CMV treatment-related myelosuppression, nephrotoxicity or other toxicities, measured using patient records from the first CMV episode until the end of follow-up 9. CMV resistance measured using patient records from the first CMV episode until the end of follow-up 10. CMV-associated mortality measured using patient records 11. All-cause mortality measured using patient records *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first.

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Secondary

Measure	Time frame
1. CMV prophylaxis and pre-emptive therapy, management of CMV reactivation/recurrence, measured from transplant date until the end of follow-up 2. Frequency of first-, second,- and third-line anti-CMV agents, measured using patient records from the first CMV episode until the end of follow-up 3. Time from HSCT to incident CMV-specific anti-viral therapy, measured using patient records 4. Viral load measured using patient records at transplant date and from 14 days prior to the start through the end of CMV episodes or until clearance 5. Medication utilization measured using patient records from transplant date until the end of follow-up 6. Demographics, diagnosis, transplant procedure, clinical, prior transplants, transplant indication, HCT comorbidity index comorbidities and score, prophylactic immunosuppressive regimen, measured using patient records at a pre-transplant time 7. Viral infections and prophylactic/treatment immunosuppressive regimen measured using patient records from transplant date until the end of follow-up 8. Viral infections, incidence and time to acute and chronic graft vs host disease (GVHD) and immunosuppressive regimen, measured using patient records from transplant date until the end of follow-up 9. Inpatient healthcare utilization, length of hospital stay, cause of hospitalization and number of outpatient clinic visits, measured using patient records from transplant date until the end of follow-up *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first.	—

Measure

Time frame

1. CMV prophylaxis and pre-emptive therapy, management of CMV reactivation/recurrence, measured from transplant date until the end of follow-up 2. Frequency of first-, second,- and third-line anti-CMV agents, measured using patient records from the first CMV episode until the end of follow-up 3. Time from HSCT to incident CMV-specific anti-viral therapy, measured using patient records 4. Viral load measured using patient records at transplant date and from 14 days prior to the start through the end of CMV episodes or until clearance 5. Medication utilization measured using patient records from transplant date until the end of follow-up 6. Demographics, diagnosis, transplant procedure, clinical, prior transplants, transplant indication, HCT comorbidity index comorbidities and score, prophylactic immunosuppressive regimen, measured using patient records at a pre-transplant time 7. Viral infections and prophylactic/treatment immunosuppressive regimen measured using patient records from transplant date until the end of follow-up 8. Viral infections, incidence and time to acute and chronic graft vs host disease (GVHD) and immunosuppressive regimen, measured using patient records from transplant date until the end of follow-up 9. Inpatient healthcare utilization, length of hospital stay, cause of hospitalization and number of outpatient clinic visits, measured using patient records from transplant date until the end of follow-up *Time of follow-up: at least 365 days after being designated as refractory, resistant or intolerant for the first time or until death, whichever comes first.

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Countries

England, France, Germany, Italy, Spain, United Kingdom, United States of America, Wales

Contacts

Public ContactIshan Hirji

ishan.hirji@takeda.com+1 (0)6175888190

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026