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

Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436384
• Other study ID #: 05-0265-AE
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2007
• Last updated: April 15, 2008
• Start date: November 2005
• Est. completion date: March 2008

Study information

• Verified date: February 2007
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Transplant

Intervention

Procedure:
• Monitoring-blood samples drawn for CMV testing

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada,