Cytomegalovirus infection in transplanted patients Infections and Infestations
Conditions
Interventions
The study will use the healthcare information that has already been documented from January 1, 2014 (until no later than determined at site level) related to the SOT, CMV infections and outcomes inclu
Sponsors
Takeda (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years at the time of the SOT 2. Received a SOT after January 1, 2014 3. Diagnosed with CMV infection any time after the SOT date 4. Required =1 anti-CMV agent to manage CMV infection and were (a) resistant to currently available treatments OR (b) refractory to currently available treatments OR (c) 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
Exclusion criteria
Exclusion criteria: Positive test for HIV before the SOT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient outcomes measured using patient records: 1. Number of CMV viremia episodes 2. Time to CMV viremia clearance and control 3. Incidence and time to CMV recurrence 4. Incidence of tissue invasive disease, CMV syndrome, graft rejection, graft loss, anti-CMV treatment-related myelosuppression, nephrotoxicity, or CMV resistance 5. Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient outcomes measured using patient records: 1. Frequency of first-, second-and third-line anti-CMV therapies, duration of therapy and time to second-line (or third-line) therapy; time to incident CMV infection and treatment initiation, viral load at time of treatment initiation or switch; medication utilization. 2. Patient pre-transplant characteristics: demographics, transplant indication, viral coinfections, significant comorbidities, underlying immunodeficiencies; Clinical / transplant characteristics; Risk factors for resistant/refractory/intolerant CMV 3. Inpatient/outpatient healthcare utilization; length of hospital stay; diagnostic tests; CMV resistance testing; anti-CMV toxicity management. | — |
Countries
England, France, Germany, Spain, United Kingdom, United States of America
Contacts
Public ContactIshan Hirji
Outcome results
None listed