Rates of cytomegalovirus among children with organ transplants

Study type
Protocol
Date of Approval
Study reference ID
16_183
Lay Summary

People who receive organ transplants such as liver, kidney or bone marrow transplant must take drugs to suppress the immune system to stop their body from rejecting the new organ. However, suppressing the immune system (immunosuppression) can make people more likely to get other infections such as cytomegalovirus (CMV), a herpes-like virus. We propose a study that will estimate the rate of CMV in children who have had an organ transplant. This will help drug companies understand how often immunosuppression is a problem in children who have had organ transplants so that appropriate patient follow-up can be provided.

Technical Summary

Using data from the CPRD, we intend to calculate the incidence rate (IR) of cytomegalovirus (CMV) in a paediatric population of organ transplant recipients. We will study all transplant recipients aged <18 and follow them from first transplant code until the end of their record or first CMV code. We will calculate the IR as the number of cases over person time at risk.

Health Outcomes to be Measured

We will assess the rate of CMV in children who have had an organ transplant at any time in the CPRD data, including transplant of the liver, kidney, heart, lung, pancreas, intestine, or bone marrow. We will start following the children at the date of the first transplant, including those recorded prior to patient registration. CMV cases will be children in the study population who have a CMV code sometime after the first transplant date.

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Susan Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program