Adenovirus Infections, HumanAdVanceNCT04285788
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients
An observational study of Adenovirus Infections, Human, run by Jazz Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 0 months to 90 years
- Conditions the study is for
- Adenovirus Infections, Human
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: compromised of all allo-HCT recipients at participating centers during the pre-specified study period
Who may be able to join
- 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
Who cannot join
- AdV negative
About this study
Official title: 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.
- Conditions
- Adenovirus Infections, Human
- Medical subject headings
- Adenovirus Infections, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6 months after first adenovirus viremia
Secondary outcomes (2)
Number of participants who were hospitalized To assess the number of hospitalizations
To assess the number of hospitalizations, length of stay, and ICU stay.
Measured: 3 to 6 months
The rate of adenovirus infection progression
To assess the rate of progression to disseminated adenovirus disease within the first year following allo-HCT
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startJan 2013
- Primary completionSep 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenovirus Infections, HumanStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285788
- Sponsor's protocol ID
- AdVance
- Acronym
- AdVance
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogeneic Hematopoietic Cell Transplant Recipients: AdVance
- ClinicalTrials.gov ID
- NCT04285788
- Acronym / sponsor ID
- AdVance / AdVance
- Conditions
- Adenovirus Infections, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- compromised of all allo-HCT recipients at participating centers during the pre-specified study period
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- AdV negative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Number of participants who were hospitalized To assess the number of hospitalizations
Time frame: 3 to 6 months
The rate of adenovirus infection progression
Time frame: 3 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenovirus Infections, Human, run by Jazz Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.