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PREDICT Cytomegalovirus (CMV)

NCT03300882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 84

Last updated 2020-08-06

No results posted yet for this study

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.

Conditions

  • Lung Transplant

Interventions

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.

Sponsors & Collaborators

  • Clinical Trials in Organ Transplantation

    collaborator NETWORK

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Laurie Snyder, MD, MHS · Duke University Medical Center: Transplantation

  • Scott Palmer, MD, MHS · Duke University Medical Center: Transplantation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-11-25
Completion
2019-11-25

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300882 on ClinicalTrials.gov