Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
QFT-CMV
1 other identifier
interventional
134
2 countries
6
Brief Summary
The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedAugust 2, 2022
July 1, 2022
3.7 years
February 10, 2016
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptomatic CMV disease
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
1 year
Secondary Outcomes (2)
Occurrence of CMV viremia
1 year
positive vs. negative cell-mediated immunity assays
1 year
Study Arms (1)
Quantiferon-CMV assay
OTHERAll patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design
Interventions
Eligibility Criteria
You may qualify if:
- Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
- CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy
You may not qualify if:
- Unable to comply with protocol
- Campath (Alemtuzumab) induction
- Receiving another investigational compound for CMV treatment or prophylaxis.
- Allergy to valganciclovir or ganciclovir
- Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3, Canada
St. Paul's Hospital - Providence Health
Vancouver, British Columbia, V6Z 1Y6, Canada
London Health Sciences Centre
London, Ontario, N6A 4V2, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 2T2, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.
PMID: 32504089DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Atul Humar, MD
University Health Network, Toronto
- PRINCIPAL INVESTIGATOR
Deepali Kumar, MD
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
May 27, 2016
Study Start
June 1, 2016
Primary Completion
February 1, 2020
Study Completion
April 1, 2020
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share