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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

April 17, 2009
July 20, 2011
June 2001
March 2012   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00886158 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood, urine, kidney biopsy tissue

Non-Probability Sample

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

Viral Infections
Not Provided
Solid Organ Transplant Recipients
Solid organ transplant recipients receiving their care at Seattle Children's Hospital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact: Jodi Smith, MD, MPH 206-987-2524 jodi.smith@seattlechildrens.org
United States
 
NCT00886158
Viral PTLD
No
Jodi Smith, MD, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: Jodi Smith, MD, MPH Seattle Children's Hospital
Seattle Children's Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP