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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33378

Enrollment

Registered

2009-09-11

Start date

2010-03-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus infection viral infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The secondary endpoint is prediction of CMV viremia and the value of measurement of CMI at other times points.	—

Countries

Netherlands

Outcome results