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

Adenovirus Infections, Human Clinical Trial

— AdVance  

Official title:

Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogeneic Hematopoietic Cell Transplant Recipients: AdVance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285788
• Other study ID #: AdVance
• Status: Completed
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: March 2022
• Source: Chimerix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 2017
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoviridae Infections
• Adenovirus Infections, Human
• Communicable Diseases
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chimerix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients	To assess non-relapse related mortality 3 to 6 months after first adenovirus viremia.	3 and 6 months after first adenovirus viremia
Secondary	Number of participants who were hospitalized To assess the number of hospitalizations	To assess the number of hospitalizations, length of stay, and ICU stay.	3 to 6 months
Secondary	The rate of adenovirus infection progression	To assess the rate of progression to disseminated adenovirus disease within the first year following allo-HCT	3 to 6 months