Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients

Completed

• Conditions: Adenovirus Infections, Human

• Registration Number: NCT04285788
• Lead Sponsor: Chimerix

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-09
• Study Completion: 2017-01
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.