Clinical trial NCT00886158: Virus Surveillance in Pediatric Solid Organ Transplant Recipients
Official title: Virus Surveillance in Pediatric Solid Organ Transplant Recipients: Identifying Risk Factors for PTLD and Other Complications Post-Transplant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Viral Infections
Keywords: Organ Transplants
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 100
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ transplant recipients receiving their care at Seattle Children's Hospital

Brief summary: Viral infections are an important complication of transplantation. Immunosuppressive therapy interferes with T cell immunity resulting in a high incidence of viral infection. Newer agents, such as mycophenolate mofetil (MMF) and sirolimus, have been associated with an increased risk of herpes virus infection. The introduction of these more potent immunosuppressive agents over the past decade correlates with an increase in the rate of hospitalizations of transplant patients with infections. This prospective study will determine the role of sub-clinical herpes virus infections in the development of complications such as chronic allograft nephropathy (CAN) and Post Transplant Lymphoproliferative Disease (PTLD). By focusing on treatable herpes virus infections, these studies have the potential to identify therapeutic strategies that can be used to diminish the burden of graft loss from CAN, significantly improving renal allograft survival and quality of life in transplant patients. Future specific interventions to test the hypothesis of a direct causal relationship between sub-clinical herpes virus infection and CAN may include the use of anti-viral therapy in response to sub-clinical infection of the renal allograft and/or peripheral blood.


Eligibility criteria: Inclusion Criteria:

* Age from birth to 21 years
* All solid organ transplant recipients receiving their care at Seattle Children's Hospital
* Signed consent, and when age appropriate, signed assent

Exclusion Criteria:

* Lack of consent

Primary outcomes:
measure: To evaluate real-time quantitative PCR levels of EBV DNA for its ability to diagnose EBV infection (primary infection or reactivation), predict the development of PTLD, and compare the results to present standard of care (semi-quantitative PCR).
timeFrame: Specimens will be collected at the following time points post-transplant: Week 2, Week 4, Week 8, Week 10, Week 12, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 15, Month 18, Month 21, Month 24
Secondary outcomes:
measure: To describe the characteristics of EBV, CMV, HHV-6 and HHV-7 infection in the solid organ transplant population.
timeFrame: Specimens will be collected at the following time points post-transplant: Week 2, Week 4, Week 8, Week 10, Week 12, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 15, Month 18, Month 21, Month 24
measure: To establish a tissue bank for the pediatric solid organ transplant population to allow for timely screening of this high-risk population when new technology becomes available and/or when new infectious agents are discovered
timeFrame: Specimens are collected at the following timepoints post transplant: 3-6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jodi Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: