Cell Mediated Immunity With Risk of Cytomegalovirus (CMV) in Solid Organ Transplant Recipients (ViracorCMI)
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|ClinicalTrials.gov Identifier: NCT01558037|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : April 5, 2013
Cytomegalovirus (CMV) is a common infection with 60-90% of all adults worldwide having evidence of having the infection at sometime in their life. Patients who have undergone transplantation are at risk at developing CMV, especially those patients who do not have antibodies to CMV pre-transplant, but received an organ from a recipient who has antibodies to CMV. Usually the disease CMV causes is mild and sometimes patients are not even aware they have the infection without tests to detect the virus. CMV can less commonly cause serious infections that affect many parts of the body including the intestines, liver, or lungs. In rare cases CMV infection in transplant patients can cause death.
All patients who receive a transplant are monitored for CMV infection. The purpose of this study is to determine if there is a way the investigators can determine in advance which patients are at greatest risk of CMV infection. Specifically, this study will analyze the immune system of transplant patients to determine if there are specific elements of the immune system that 1) helps protect the body against CMV infection, and 2) helps the body combat CMV once it is infected. Identifying these specific elements of the immune system could improve the physician's ability to monitor the SOT patients for CMV infection, and to help treat CMV in those patients that become infected.
|Condition or disease|
|Awaiting Organ Transplant Infection in Solid Organ Transplant Recipients|
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|Official Title:||A Study to Correlate CMV-Specific Cell Mediated Immunity With Risk of CMV Disease and With Clinical Response to Therapy Following Solid Organ Transplantation|
|Study Start Date :||April 2010|
|Primary Completion Date :||December 2011|
|Study Completion Date :||March 2012|
Main study patients are enrolled before or at time of solid organ transplant. Qualifying subjects either have tested positive for Cytomegalovirus or have a donor who has tested positive for Cytomegalovirus.
Subjects are enrolled to this arm who have begun replicating Cytomegalovirus post transplant. These subjects may or may not have been on the main study arm.
- Assessment of CMV Cell-Mediated Immune Response [ Time Frame: For 8 months after transplant or 4 months after clearance of CMV ]Association between CMV CMI response and both the risk of CMV infection and the degree of initial CMV viremia and rate of viremia clearance with standard CMV therapy
- Assessment of CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI [ Time Frame: For 8 months after transplant or 4 months after clearance of CMV ]
Association between CMV QnPCR, CMV microRNA expression, TLR2 expression, and CMV-specific CMI collected at CMV infection and the following prospective data:
- Development of CMV end organ disease
- Resolution of symptoms of CMV infection
- Other non-CMV infections after initial CMV infection
- Graft rejection
- Recurrent or resistant CMV infection
- Other markers of immune function
- Type of SOT
- CMV donor/recipient status
- Type and degree of immunosuppression
- Type and length of CMV prophylaxis
- Prior graft rejection and infections (non-CMV)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558037
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Michael G Ison, MD,MS||Northwestern University|