Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-11 @ 7:42 PM
Study NCT ID:
NCT02784756
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2016-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QFT-CMV
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: