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

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.

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Key information

Conditions

Adenovirus Infections, Human Adenoviridae Infections DNA Virus Infections Infections Virus Diseases

Age range

0 month–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients

Time frame: 3 and 6 months after first adenovirus viremia

To assess non-relapse related mortality 3 to 6 months after first adenovirus viremia.

Secondary outcomes

Number of participants who were hospitalized To assess the number of hospitalizations

Time frame: 3 to 6 months

To assess the number of hospitalizations, length of stay, and ICU stay.
The rate of adenovirus infection progression

Time frame: 3 to 6 months

To assess the rate of progression to disseminated adenovirus disease within the first year following allo-HCT

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: AdVance

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2017
First posted: Feb 26, 2020
Registry last updated: Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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