Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients (QFT-CMV)
Primary Purpose
Cytomegalovirus Viraemia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Quantiferon-CMV assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Cytomegalovirus Viraemia focused on measuring Quantiferon-CMV, solid organ transplant, CMV Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Alberta Hospital
- St. Paul's Hospital - Providence Health
- London Health Sciences Centre
- St. Michael's Hospital
- University Health Network, Toronto General Hospital
- Hospital Universitario 12 de Octubre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Quantiferon-CMV assay
Arm Description
All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design
Outcomes
Primary Outcome Measures
Symptomatic CMV disease
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
Secondary Outcome Measures
Occurrence of CMV viremia
Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL)
positive vs. negative cell-mediated immunity assays
Incidence of positive vs. negative cell-mediated immunity assays post-transplant
Full Information
NCT ID
NCT02784756
First Posted
February 10, 2016
Last Updated
July 29, 2022
Sponsor
University Health Network, Toronto
Collaborators
Canadian National Transplant Research Program
1. Study Identification
Unique Protocol Identification Number
NCT02784756
Brief Title
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
Acronym
QFT-CMV
Official Title
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian National Transplant Research Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Viraemia
Keywords
Quantiferon-CMV, solid organ transplant, CMV Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quantiferon-CMV assay
Arm Type
Other
Arm Description
All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design
Intervention Type
Device
Intervention Name(s)
Quantiferon-CMV assay
Primary Outcome Measure Information:
Title
Symptomatic CMV disease
Description
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Occurrence of CMV viremia
Description
Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL)
Time Frame
1 year
Title
positive vs. negative cell-mediated immunity assays
Description
Incidence of positive vs. negative cell-mediated immunity assays post-transplant
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Humar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deepali Kumar, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
St. Paul's Hospital - Providence Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32504089
Citation
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.
Results Reference
derived
Learn more about this trial
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
We'll reach out to this number within 24 hrs