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

Cytomegalovirus Viraemia Clinical Trial

— QFT-CMV  

Official title:

Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784756
• Other study ID #: 15-9877
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2020

Study information

• Verified date: July 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Cytomegalovirus Viraemia
• Viremia

Intervention

Device:
• Quantiferon-CMV assay

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital - Providence Health	Vancouver	British Columbia
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian National Transplant Research Program

Countries where clinical trial is conducted

Canada,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of CMV viremia	Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL)	1 year
Secondary	positive vs. negative cell-mediated immunity assays	Incidence of positive vs. negative cell-mediated immunity assays post-transplant	1 year