Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00436384
First received: February 15, 2007
Last updated: April 15, 2008
Last verified: February 2007
  Purpose

Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.


Condition Intervention Phase
Transplant
Procedure: Monitoring-blood samples drawn for CMV testing
Phase 4

Study Type: Observational
Official Title: Cell Mediated Immunity and the Prediction of CMV Infection In Solid Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 150
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients who fulfill the following criteria are eligible for inclusion.

    • CMV D+/R- liver, kidney and heart recipient
    • CMV R+ liver,kidney and heart recipients who have received thymoglobulin induction therapy.
    • D+/R- and R+ lung transplant recipients.
    • Able to give written informed consent
    • Are willing and able to comply with the protocol
    • Age >=18 years

Exclusion Criteria:

  • Patient unwilling or unable to give informed 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: NCT00436384

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Atul Humar, MD University Health Network, Toronto
Principal Investigator: Deepali Kumar, MD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436384     History of Changes
Other Study ID Numbers: 05-0265-AE
Study First Received: February 15, 2007
Last Updated: April 15, 2008
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
liver transplant
lung transplant
kidney transplant
heart transplant
CMV CMI

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014