Virus Surveillance in Pediatric Solid Organ Transplant Recipients

Virus Surveillance in Pediatric Solid Organ Transplant Recipients: Identifying Risk Factors for PTLD and Other Complications Post-Transplant

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.

Study Overview

• Status: Unknown
• Conditions: Viral Infections

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jodi Smith, MD, MPH; Phone Number: 206-987-2524; Email: jodi.smith@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Jodi Smith, MD
      • Contact: Jodi Smith, MD, MPH; Phone Number: 206-987-2524; Email: jodi.smith@seattlechildrens.org
      • Contact: Libby Brockman, BS; Phone Number: 206-987-8249; Email: libby.brockman@seattlechildrens.org
      • Sub-Investigator: Ruth McDonald, MD
      • Sub-Investigator: Connie Davis, MD
      • Sub-Investigator: Patrick Healey, MD
      • Sub-Investigator: Karen Murray, MD
      • Sub-Investigator: Simon Horslen, MD
      • Sub-Investigator: Kelly Hansen, ARNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Solid organ transplant recipients receiving their care at Seattle Children's Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Solid Organ Transplant Recipients; Solid organ transplant recipients receiving their care at Seattle Children's Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Jodi Smith, MD, MPH, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 21, 2009
• First Posted (Estimate): April 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Organ Transplants
• Additional Relevant MeSH Terms: Infections; Virus Diseases
• Other Study ID Numbers: Viral PTLD