Cell mediated immunity and the prediction of CMV disease in solid organ transplant recipients

Completed

• Conditions: Cytomegalovirus infection; viral infection; 10047438

• Registration Number: NL-OMON33378
• Lead Sponsor: niversity of Alberta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Adult CMV D+/R- liver transplant recipients
AND
2. All eligible patients must be scheduled to receive 3 months of either valganciclovir, oral ganciclovir, or intravenous ganciclovir prophylaxis

Exclusion Criteria

1. Scheduled to receive longer or shorter than 3-6 months of prophylaxis
OR
2. Unable to provide informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is value of the assay result at the end of<br /><br>prophylaxis for the prediction of CMV disease within the 6 months after<br /><br>stopping prophylaxis. Follow-up will be at 12 months for all patients. The<br /><br>definition of CMV disease will be based on the criteria recommended by the AST<br /><br>for use in clinical trials.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is prediction of CMV viremia and the value of<br /><br>measurement of CMI at other times points. </p><br>