Status:
COMPLETED
PREDICT Cytomegalovirus (CMV)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Clinical Trials in Organ Transplantation
Rho Federal Systems Division, Inc.
Conditions:
Lung Transplant
Eligibility:
All Genders
18+ years
Brief Summary
The overall objective of this study is to establish a personalized test to measure individualized cytomegalovirus (CMV) specific immunity in lung transplant recipients in an effort to guide antiviral ...
Detailed Description
Cytomegalovirus (CMV) is a common virus. The virus is spread from one person to another through infected body fluids. In those with a normal immune system, CMV does not cause much of a problem. The im...
Eligibility Criteria
Inclusion
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- Must be able to understand and provide written informed consent;
- Anticipated listing for lung transplantation OR listed for lung transplant OR is within 45 days of having received a single or bilateral cadaveric donor lung transplant;
- Undergoing first lung transplant operation;
- Transplant surgery to be performed or performed at enrolling center;
- Concurrent participation in CTOT-20 (Clinical Trials.gov ID: NCT02631720); and
- CMV-seropositive lung transplant recipient, using methods in accordance with current local organ procurement organization policies.
- Note: Concurrent participation in immune monitoring studies or interventional device trials are permitted.
Exclusion
- Individuals who meet any of the following criteria are not eligible for enrollment as study participants:
- Unwilling to enroll in CTOT-20 (Clinical Trials.gov ID: NCT02631720);
- Multi-organ recipient;
- Prior recipient of any solid organ transplant, including prior lung transplant;
- Prior or concurrent recipient of bone marrow transplant;
- Human Immunodeficiency Virus (HIV) infection;
- Pregnant or planned pregnancy;
- Any condition that, in the investigator's opinion, would make it unlikely for the recipient to complete follow up procedures or complete the study; or
- Participation in an investigational drug trial at the time of enrollment visit.
Key Trial Info
Start Date :
October 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 25 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03300882
Start Date
October 31 2017
End Date
November 25 2019
Last Update
August 6 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Hospital: Transplantation
Baltimore, Maryland, United States, 21287
2
Duke University Medical Center: Transplantation
Durham, North Carolina, United States, 27710
3
Cleveland Clinic Foundation: Transplantation
Cleveland, Ohio, United States, 44195
4
Toronto General Hospital: Transplantation
Toronto, Canada, M5G 2C4