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PREDICT Cytomegalovirus (CMV) (PREDICT CMV)

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ClinicalTrials.gov Identifier: NCT03300882
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
Lung Transplant Other: Procedure

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.


Study Type : Observational
Estimated Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Cytomegalovirus (CMV) Specific Immune Monitoring to Predict Patient Risk After Lung Transplantation (CTOT-22)
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CMV+ First Lung Transplant Recipients
Participants enrolled in one of four North American sites in clinical research study CTOT-20 (Clinical Trials.gov ID: NCT02631720) who are cytomegalovirus positive by serology (e.g., CMV Recipient positive).
Other: Procedure
Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.
Other Names:
  • Serial blood draws
  • Phlebotomy
  • Venipuncture




Primary Outcome Measures :
  1. Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease within 6 months Post CMV Prophylaxis Discontinuation [ Time Frame: From CMV Prophylaxis Discontinuation to 6 Months Post CMV Prophylaxis Discontinuation ]
    Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.

  2. Time from CMV Prophylaxis Discontinuation Post-Transplant to First Detection of CMV Infection or CMV Disease Within 18 Months Post-Transplant [ Time Frame: From CMV Prophylaxis Discontinuation to 18-Months Post-Transplant ]
    Participants will be evaluated for CMV infection or disease according to each center's standard of care clinical protocol. All centers have aligned their clinical practice to include, at a minimum, a CMV infection and a CMV disease assessment at the time of prophylaxis discontinuation, monthly for the first 6 months after discontinuation, and quarterly after that up to 18 months post transplantation.


Biospecimen Retention:   Samples With DNA
Peripheral blood mononuclear cells (PBMCs) and plasma.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.

Information from the National Library of Medicine

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): NCT03300882


Locations
United States, Maryland
Johns Hopkins Hospital: Transplantation Recruiting
Baltimore, Maryland, United States, 21287
Contact: Joby Mathew    410-550-6458    jmathe27@jhmi.edu   
Principal Investigator: Pali Shah, MD         
United States, North Carolina
Duke University Medical Center: Transplantation Recruiting
Durham, North Carolina, United States, 27710
Contact: Allie Frear    919-684-8914    allie.frear@dm.duke.edu   
Principal Investigator: John M Reynolds, MD         
United States, Ohio
Cleveland Clinic Foundation: Transplantation Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Bette Maierson    216-444-2901    maierse@ccf.org   
Principal Investigator: Marie Budev, DO         
Canada
Toronto General Hospital: Transplantation Not yet recruiting
Toronto, Canada, M5G 2C4
Contact: Anam Islam    (416) 340-4800 ext 6740    anam.islam@uhnresearch.ca   
Principal Investigator: Lianne Singer, MD         
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
Study Chair: Laurie Snyder, MD, MHS Duke University Medical Center: Transplantation
Study Chair: Scott Palmer, MD, MHS Duke University Medical Center: Transplantation

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03300882     History of Changes
Other Study ID Numbers: DAIT CTOT-22
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Study co-enrollment (CTOT-20 and CTOT-22)
cytomegalovirus (CMV)
CMV seropositive positive recipient
CMV infection
CMV-specific immunity
immunologic monitoring