Clinical Evaluation of the QuantiFERON CMV Assay

Qiagen

Status: Terminated

Conditions: CMV

Treatments: Device: QuantiFERON CMV Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03502161

C16-CMV-001

Details and patient eligibility

About

Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
• Scheduled to receive between 3 to 6 months of antiviral prophylaxis
• Provide Informed Consent

Exclusion criteria

• Subjects less than 18 years old
• Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
• Unable to provide Informed Consent

Trial design

8 participants in 1 patient group

All subjects

Description:

Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis.

Treatment:

Device: QuantiFERON CMV Assay