PREDICT Cytomegalovirus (CMV)

Completed

Conditions studied: Lung Transplant

In brief

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 prophylaxis duration in clinical practice. Targeted participants are those: * enrolled in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who * are CMV recipient positive by serology as determined using methods in accordance with current local organ procurement organization policies.

Key facts

Study ID

NCT03300882

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

84

Starts

2017-10-31

Expected to finish

2019-11-25

Last updated by the study team

2020-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Johns Hopkins Hospital: Transplantation — Baltimore, Maryland, United States
• Duke University Medical Center: Transplantation — Durham, North Carolina, United States
• Cleveland Clinic Foundation: Transplantation — Cleveland, Ohio, United States
• Toronto General Hospital: Transplantation — Toronto, Canada

Full record on ClinicalTrials.gov

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