Virus Surveillance in Pediatric Solid Organ Transplant Recipients

• Conditions: Viral Infections

• Registration Number: NCT00886158
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• Lack of consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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 Outcome Measures

Name	Time	Method
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	Specimens are collected at the following timepoints post transplant: 3-6 months, 12 months, and 24 months
To describe the characteristics of EBV, CMV, HHV-6 and HHV-7 infection in the solid organ transplant population.	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

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States