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

Not Applicable

Completed

• Conditions: Cytomegalovirus Viraemia
• Interventions: Device: Quantiferon-CMV assay

• Registration Number: NCT02784756
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Study Start: 2016-06
• Primary Completion: 2020-02
• Study Completion: 2020-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quantiferon-CMV assay	Quantiferon-CMV assay	All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design

Primary Outcome Measures

Name	Time	Method
Symptomatic CMV disease	1 year	Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.

Secondary Outcome Measures

Name	Time	Method
Occurrence of CMV viremia	1 year	Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (\> 1000 IU/mL)
positive vs. negative cell-mediated immunity assays	1 year	Incidence of positive vs. negative cell-mediated immunity assays post-transplant

Trial Locations

Locations (6)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Paul's Hospital - Providence Health; 🇨🇦 Vancouver, British Columbia, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

University Health Network, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada