Virus Surveillance in Pediatric Solid Organ Transplant Recipients
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Purpose
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.
| Condition |
|---|
|
Viral Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Virus Surveillance in Pediatric Solid Organ Transplant Recipients: Identifying Risk Factors for PTLD and Other Complications Post-Transplant |
- 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). [ Time Frame: 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 ] [ Designated as safety issue: No ]
- To describe the characteristics of EBV, CMV, HHV-6 and HHV-7 infection in the solid organ transplant population. [ Time Frame: 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 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Specimens are collected at the following timepoints post transplant: 3-6 months, 12 months, and 24 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood, urine, kidney biopsy tissue
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Solid Organ Transplant Recipients
Solid organ transplant recipients receiving their care at Seattle Children's Hospital
|
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Solid organ transplant recipients receiving their care at Seattle Children's Hospital
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
Contacts and Locations| Contact: Jodi Smith, MD, MPH | 206-987-2524 | jodi.smith@seattlechildrens.org |
| United States, Washington | |
| Seattle Children's Hospital | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Jodi Smith, MD, MPH 206-987-2524 jodi.smith@seattlechildrens.org | |
| Contact: Libby Brockman, BS 206-987-8249 libby.brockman@seattlechildrens.org | |
| Principal Investigator: Jodi Smith, MD | |
| 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 | |
| Principal Investigator: | Jodi Smith, MD, MPH | Seattle Children's Hospital |
More Information
No publications provided
| Responsible Party: | Jodi Smith, MD, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00886158 History of Changes |
| Other Study ID Numbers: | Viral PTLD |
| Study First Received: | April 17, 2009 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Seattle Children's Hospital:
|
Organ Transplants |
Additional relevant MeSH terms:
|
Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013