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Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients (QFT-CMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02784756
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : April 11, 2018
Canadian National Transplant Research Program
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Viraemia Device: Quantiferon-CMV assay Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
Study Start Date : June 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Quantiferon-CMV assay
All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design
Device: Quantiferon-CMV assay

Primary Outcome Measures :
  1. 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 Measures :
  1. Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL) [ Time Frame: 1 year ]
  2. Incidence of positive vs. negative cell-mediated immunity assays post-transplant [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02784756

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Contact: Deepali Kumar, MD, FRCP(C) 416-340-4241

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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Carlos Cervera, MD    780-492-0278   
Contact: Sonia Fuentes, MD    780-492-0278   
Canada, British Columbia
St. Paul's Hospital - Providence Health Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: John Gill, MD    604-682-2344 ext 64707   
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Seyed Hosseini, MD    519-685-8500 ext 3476   
Contact: Samantha Parsons    519-685-8500 ext 3476   
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Jeff Zaltzman, MD    416-867-7444   
Contact: Michelle Nash    416-867-3692   
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Natalia Pinzon    416-340-4800 7393 ext 7393   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Mario Fernandez, MD    +349136908000 ext 4631   
Sponsors and Collaborators
University Health Network, Toronto
Canadian National Transplant Research Program
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Principal Investigator: Atul Humar, MD University Health Network, Toronto
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT02784756     History of Changes
Other Study ID Numbers: UHN-TID-003
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University Health Network, Toronto:
solid organ transplant
CMV Disease

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Herpesviridae Infections
DNA Virus Infections