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Virus Surveillance in Pediatric Solid Organ Transplant Recipients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seattle Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00886158
First received: April 17, 2009
Last updated: July 20, 2011
Last verified: July 2011
  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

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886158

Contacts
Contact: Jodi Smith, MD, MPH 206-987-2524 jodi.smith@seattlechildrens.org

Locations
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         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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 November 20, 2014