Cytomegalovirus ViraemiaQFT-CMVNCT02784756
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
A study testing Quantiferon-CMV assay in people with Cytomegalovirus Viraemia, run by University Health Network, Toronto at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Viraemia
- What is being tested?
- Quantiferon-CMV assay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2016to Apr 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada5 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3
London Health Sciences Centre
London, Ontario, N6A 4V2
St. Michael's Hospital
Toronto, Ontario, M5C 2T2
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2N2
St. Paul's Hospital - Providence Health
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
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.
Read the 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.
- Conditions
- Cytomegalovirus Viraemia
- Being tested
- Quantiferon-CMV assay
- Keywords
- Quantiferon-CMV, solid organ transplant, CMV Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantiferon-CMV assayDevice
| Study group | Role | What they receive |
|---|---|---|
| Quantiferon-CMV assay | Other | All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design Receives: Device: Quantiferon-CMV assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic CMV disease
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
Measured: 1 year
Secondary outcomes (2)
Occurrence of CMV viremia
Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL)
Measured: 1 year
positive vs. negative cell-mediated immunity assays
Incidence of positive vs. negative cell-mediated immunity assays post-transplant
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus ViraemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian National Transplant Research Program
- Responsible party
- Sponsor
- Investigators
- Atul Humar, MD, Principal investigator, University Health Network, TorontoDeepali Kumar, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784756
- Sponsor's protocol ID
- 15-9877
- Acronym
- QFT-CMV
- Status last verified
- Jul 2022
- First submitted
- 10 Feb 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32504089
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
- ClinicalTrials.gov ID
- NCT02784756
- Acronym / sponsor ID
- QFT-CMV / 15-9877
- Conditions
- Cytomegalovirus Viraemia
- Keywords
- Quantiferon-CMV, solid organ transplant, CMV Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian National Transplant Research Program
- Study start
- Jun 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantiferon-CMV assay | Other | Device: Quantiferon-CMV assayAll patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantiferon-CMV assay | Device | Quantiferon-CMV assay |
Primary outcome
Symptomatic CMV disease
Time frame: 1 year
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
2 secondary outcomes
Occurrence of CMV viremia
Time frame: 1 year
positive vs. negative cell-mediated immunity assays
Time frame: 1 year
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 2 Aug 2022.
- Derived from this study: PubMed 32504089Gibson 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.
- Individual participant dataSharing planned: No
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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.
Atul Humar, MD principal investigator
University Health Network, Toronto
Deepali Kumar, MD principal investigator
University Health Network, Toronto
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantiferon-CMV assay in people with Cytomegalovirus Viraemia, run by University Health Network, Toronto at 6 sites in 2 countries.
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 5 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Symptomatic CMV disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784756, which also lists 1 linked publication.
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 2 Aug 2022.