Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT00886158

Conditions

Viral Infections

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Viral Infections

Study ID

NCT00886158

Start date

Jun, 2001

Status verified date

Jul, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Solid Organ Transplant Recipients

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

Primary outcome 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). [ 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 ]

Central Contacts and Locations

Central contacts

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Jodi Smith, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jul 22, 2011

Last verified

Jul, 2011

Keywords

  • Organ Transplants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2011-07-22.