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T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays — PROTECT  

Infection in Solid Organ Transplant Recipients Clinical Trial

Official title:
A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection

Clinical Trial Summary

The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT platform technology can be applied to diagnose and monitor any major disease process driven by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).

Clinical Trial Description

Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis.

Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation.

Study population:

All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant. ;

Study Design

Related Conditions & MeSH terms

  • Infection
  • Infection in Solid Organ Transplant Recipients
Clinical Trial Details
NCT number NCT02382211
Study type Observational
Source Oxford Immunotec
Contact
Status Completed
Phase
Start date January 2015
Completion date September 2017
View Details
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