NCT03502161

Brief Summary

Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

April 4, 2018

Last Update Submit

September 14, 2020

Conditions

CMV

Outcome Measures

Primary Outcomes (1)

  • Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.

    Measurement of QF-CMV result

    At time of prophylaxis termination, +1 month from termination, +2 months from termination

Study Arms (1)

All subjects

Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis.

Device: QuantiFERON CMV Assay

Interventions

QuantiFERON CMV AssayDEVICE

Assay to measure cell-mediated immune function using QuantiFERON CMV assay.

All subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.

You may qualify if:

  • Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
  • Scheduled to receive between 3 to 6 months of antiviral prophylaxis
  • Provide Informed Consent

You may not qualify if:

  • Subjects less than 18 years old
  • Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
  • Unable to provide Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.

    BACKGROUND

  • Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20.

    PMID: 11229841BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Residual Plasma

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 18, 2018

Study Start

November 15, 2018

Primary Completion

May 15, 2020

Study Completion

June 30, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)