Clinical trial NCT03300882: PREDICT Cytomegalovirus (CMV)
Official title: Prospective Multicenter Cytomegalovirus (CMV) Specific Immune Monitoring to Predict Patient Risk After Lung Transplantation (CTOT-22)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant
Keywords: Study co-enrollment (CTOT-20 and CTOT-22)
cytomegalovirus (CMV)
CMV seropositive positive recipient
CMV infection
CMV-specific immunity
immunologic monitoring
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation
name: Rho Federal Systems Division, Inc.
First posted: 2017-10-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult lung transplant recipients undergoing lung transplant at one of the four participating centers and concurrently enrolled in CTOT-20 (Clinical Trials.gov ID: NCT02631720).

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 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.

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 immune system keeps the virus under control so most people do not have any symptoms. Once infected, the virus usually stays dormant (inactive) in the body for a person's entire life. This means some of the cells in the body are infected and the virus can become active again.

Lung transplant recipients take anti-rejection medicines to prevent the body from rejecting the transplanted lung(s). Although anti-rejection medications help protect the transplanted lung(s) from the body's immune system, these medications also decrease the body's ability to fight infections. This reduces the immune system's ability to control viruses like CMV. Many transplant recipients take an antiviral medication early after transplant to help the body control the CMV virus. This is the time that risk of infection would be highest. Sometimes recipients get an active CMV infection after stopping these medicines. If this happens, the infection is treated and monitored.

In this study, investigators are trying to determine whether a blood test can predict development of active CMV infection in lung transplant recipients. Specifically, the clinical research study will prospectively assess the performance of an immune signature based on the "ex vivo" measurement of T cell CMV specific immunity in predicting freedom from future CMV infections among recipient positive (R+) lung transplant participants receiving standard durations of valganciclovir prophylaxis.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital: Transplantation
state: Maryland
city: Durham
country: United States
facility: Duke University Medical Center: Transplantation
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation: Transplantation
state: Ohio
city: Toronto
country: Canada
facility: Toronto General Hospital: Transplantation
Study officials:
affiliation: Duke University Medical Center: Transplantation
name: Laurie Snyder, MD, MHS
role: STUDY_CHAIR
affiliation: Duke University Medical Center: Transplantation
name: Scott Palmer, MD, MHS
role: STUDY_CHAIR
References:
citation: Snyder LD, Chan C, Kwon D, Yi JS, Martissa JA, Copeland CA, Osborne RJ, Sparks SD, Palmer SM, Weinhold KJ. Polyfunctional T-Cell Signatures to Predict Protection from Cytomegalovirus after Lung Transplantation. Am J Respir Crit Care Med. 2016 Jan 1;193(1):78-85. doi: 10.1164/rccm.201504-0733OC.