AdVance: Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients
Sponsor
Chimerix (Industry)
Overall Status
Completed
CT.gov ID
NCT04285788
Collaborator
(none)
216
48
Study Details
Study Description
Brief Summary
To depict the incidence, outcomes and standards of care (SoC) of adenovirus (AdV) infections and associated practice patterns in allogeneic hematopoietic cell transplant recipients. It is expected that participating centers will be in the United Kingdom, France, Spain, Germany, and Italy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Study Type:
Observational
Actual Enrollment
:
216 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogeneic Hematopoietic Cell Transplant Recipients: AdVance
Actual Study Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Sep 1, 2015
Actual Study Completion Date
:
Jan 1, 2017
Outcome Measures
Primary Outcome Measures
- Number of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients [3 and 6 months after first adenovirus viremia]
To assess non-relapse related mortality 3 to 6 months after first adenovirus viremia.
Secondary Outcome Measures
- Number of participants who were hospitalized To assess the number of hospitalizations [3 to 6 months]
To assess the number of hospitalizations, length of stay, and ICU stay.
- The rate of adenovirus infection progression [3 to 6 months]
To assess the rate of progression to disseminated adenovirus disease within the first year following allo-HCT
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Months
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
At least one AdV positive test, regardless of specimen within 6 months following the first allo-HCT
-
Subjects first allo-HCT must have been performed between 1 January 2013 and 30 September 2015
Exclusion Criteria:
- AdV negative
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chimerix
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Chimerix
ClinicalTrials.gov Identifier:
NCT04285788
Other Study ID Numbers:
- AdVance
First Posted:
Feb 26, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Additional relevant MeSH terms: