CompletedNot Applicable

PREDICT Cytomegalovirus (CMV)

United States, Canada84 participantsStarted 2017-10-31

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation

Timeframe: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation

Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant

Timeframe: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant

Trial details

NCT IDNCT03300882

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-11-25

View on ClinicalTrials.gov More Lung Transplant trials