Clinical trial NCT02420080: A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
Official title: A Multicenter Non-Interventional Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adenovirus
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: allogeneic hematopoietic cell transplant (HCT) recipients who were at risk of progression to disseminated AdV disease. Allogeneic hematopoietic cell transplant recipients with disseminated AdV disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohort A (Time to progression of AdV disease through Week 36)
timeFrame: 36 weeks
Secondary outcomes:
measure: Cohort B (Time to all-cause mortality through Week 36)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Washinton
country: United States
facility: Childrens National Health System
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Bronx
country: United States
facility: The Children's Hospital at Montefiore
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hosital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St. Judes Children's Research Hospital
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialist LDS Hospital
state: Utah
city: Seattle
country: United States
facility: University of Washington_Fred Hutchinson Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: