Adenovirus
Conditions
Brief summary
The objective is data collection to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
Detailed description
The objective of this retrospective data collection is to determine background rates of adenovirus (AdV) progression and mortality in subjects with Adenovirus (AdV) infection and/or disease.
Interventions
DRUGBrincidofovir
Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 75 Years
Healthy volunteers
No
Inclusion criteria
* Matched-control cases must be recruited from sites participating in the CMX001-304 study and meet all of the following criteria, as applicable, to be eligible for data abstraction in this non-interventional retrospective study: * Age at time of transplant: ≥ 2 months * Eligible matched-control subjects must meet the disease conditions of one or both of the two cohorts listed below on or after Jan 1, 2004 and prior to Mar 12, 2014. If subjects had more than one study-qualifying episode of these disease conditions on or after Jan 1, 2004 and prior to Mar 12, 2014, only the most recent qualifying episode should be included: * Cohort A: allogeneic hematopoietic cell transplantation (HCT) recipients who were at risk of progression to disseminated AdV disease, defined as documented evidence of 1) asymptomatic AdV viremia ≥ 1,000 copies/mL, increasing, OR 2) localized AdV infection * Cohort B: allogeneic HCT recipients with disseminated AdV disease
Exclusion criteria
* Prior use of BCV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort A (Time to progression of AdV disease through Week 36) | 36 weeks | Time to progression of AdV disease through Week 36 post initial AdV diagnosis, with progression of AdV disease defined as time to the occurrence of either clinical progression to probable or definitive disseminated AdV disease or Death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort B (Time to all-cause mortality through Week 36) | 36 weeks | Time to all-cause mortality through Week 36 post diagnosis of disseminated AdV disease |
Countries
United States
Outcome results
None listed