Virus Surveillance in Pediatric Solid Organ Transplant Recipients

NCT ID: NCT00886158

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Viral Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Solid Organ Transplant Recipients

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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seattle Children's Hospital

Principal Investigators

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Jodi Smith, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jodi Smith, MD, MPH

Role: CONTACT

206-987-2524

Facility Contacts

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Jodi Smith, MD, MPH

Role: primary

206-987-2524

Libby Brockman, BS

Role: backup

206-987-8249

Other Identifiers

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Viral PTLD

Identifier Type: -

Identifier Source: org_study_id

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