Approach for defining human adenovirus infection and disease for central review adjudication in clinical studies.

ABSTRACT:

Background

Pediatric allogeneic hematopoietic cell transplant (allo-HCT) recipients are at risk for morbidity and mortality from human adenovirus (HAdV). HAdV can be detected in an asymptomatic state, referred to as infection or with signs or symptoms of illness, referred to as disease. Standardized case definitions are needed to distinguish infection from disease and allow for consistent reporting in both observational cohort studies and therapeutic clinical trials.

Methods

A working group of experts in virology, transplant infectious disease, and HCT was assembled to develop HAdV infection and disease definitions with the degree of certainty (i.e., possible, probable, and proven). Definitions were further refined through an iterative process and independently applied by tw

SUBMITTER: Fisher BT 

PROVIDER: S-EPMC11031616 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature