NCT04285788

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

February 24, 2020

Last Update Submit

March 10, 2022

Conditions

Adenovirus Infections, Human

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    3 to 6 months

  • The rate of adenovirus infection progression

    3 to 6 months

Eligibility Criteria

Age0 Months - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • AdV negative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenovirus Infections, Human

Condition Hierarchy (Ancestors)

Adenoviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

January 1, 2013

Primary Completion

September 1, 2015

Study Completion

January 1, 2017

Last Updated

March 25, 2022

Record last verified: 2022-03