Cytomegalovirus (CMV) in solid organ transplant patients
Not Applicable
Completed
- Conditions
- Cytomegalovirus infection in transplanted patientsInfections and Infestations
- Registration Number
- ISRCTN10633953
- Lead Sponsor
- Takeda (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 218
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
Positive test for HIV before the SOT
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient outcomes measured using patient records:<br>1. Number of CMV viremia episodes<br>2. Time to CMV viremia clearance and control<br>3. Incidence and time to CMV recurrence<br>4. Incidence of tissue invasive disease, CMV syndrome, graft rejection, graft loss, anti-CMV treatment-related myelosuppression, nephrotoxicity, or CMV resistance<br>5. Overall survival
- Secondary Outcome Measures
Name Time Method Patient outcomes measured using patient records:<br>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.<br>2. Patient pre-transplant characteristics: demographics, transplant indication, viral coinfections, significant comorbidities, underlying immunodeficiencies; Clinical / transplant characteristics; Risk factors for resistant/refractory/intolerant CMV<br>3. Inpatient/outpatient healthcare utilization; length of hospital stay; diagnostic tests; CMV resistance testing; anti-CMV toxicity management.