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

March 10, 2022 updated by: Chimerix

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

compromised of all allo-HCT recipients at participating centers during the pre-specified study period

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 6 months after first adenovirus viremia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 to 6 months
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
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chimerix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (ACTUAL)

February 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVANCE (European Commission)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenovirus Infections, Human

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe