Clinical Evaluation of the QuantiFERON CMV Assay

NCT ID: NCT03502161

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-15

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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CMV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All subjects

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

QuantiFERON CMV Assay

Intervention Type DEVICE

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

Interventions

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QuantiFERON CMV Assay

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 11229841 (View on PubMed)

Other Identifiers

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C16-CMV-001

Identifier Type: -

Identifier Source: org_study_id

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