Evaluation of the Artus® CMV PCR Test

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier:
NCT01034709
First received: December 15, 2009
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy.


Condition
Cytomegalovirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Artus® CMV RG PCR Test

Resource links provided by NLM:


Further study details as provided by QIAGEN Gaithersburg, Inc:

Primary Outcome Measures:
  • a) To demonstrate that the artus CMV RG PCR test tracks the viral load of the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational site. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Extracted DNA


Estimated Enrollment: 216
Study Start Date: December 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Symptomatic
Subjects with a confirmed CMV viremia by the site's CMV-LDT as well as CMV symptoms
Asymptomatic
Subjects who must have been serologically positive for CMV IgG prior to transplantation and do not have any CMV symptoms

Detailed Description:

The human Cytomegalovirus (CMV) is found in blood, tissues and nearly all secretory fluids of infected persons. Transmission can be oral, sexual, via blood transfusion, organ transplantation, intrauterine, or perinatal. Infection with CMV preadolescence frequently leads to an asymptomatic infection followed by a lifelong persistence of the virus in the body. Infection post adolescence typically leads to symptoms that resemble those of mononucleosis (e.g., fever, fatigue, hepatitis, etc.) In contrast, CMV infections in immune compromised patients can be life threatening. A major cause of virus-associated morbidity and mortality in solid organ transplantation patients is illness caused by CMV (i.e., CMV syndrome or CMV disease).

The risk of progressing to CMV disease post-transplant is strongly correlated with the serological status of the donor (D) and recipient (R); the highest risk group is R-/D+. Patients at risk for CMV disease can be managed either preemptively (i.e., patients are only treated with antiviral agents after evidence of CMV infection arises), or prophylactically (i.e., all patients are treated with antiviral agents regardless of CMV infection status). Monitoring of the CMV viral load of transplant patients during antiviral therapy provides an effective aid in the management of patients with CMV disease. The artus® CMV RG PCR test is a nucleic acid amplification-based assay for the quantitation of CMV DNA using PCR in the Rotor-Gene™ 6000 Instrument (also known as Rotor-Gene Q) with software version 2.0.2.3 or higher. In the present study the artus CMV RG PCR test result will be evaluated for its ability to safely and effectively monitor transplant patients during antiviral therapy and will be compared to the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes subjects that have received a kidney transplant, and that are hospitalized or that present to a hospital, clinic or physicians office for post-transplantation care and will be treated with ganciclovir and/or valganciclovir for symptomatic CMV infection.

Criteria

Inclusion Criteria:

  1. Subjects must have had a kidney transplant.
  2. Subjects that present at a hospital, clinic or physicians office for post-transplantation care.
  3. Subjects must be 18 years of age or older.
  4. Subjects providing informed consent.
  5. Subjects must have a CMV infection as demonstrated by a positive result by the site's CMV-PCR-Laboratory Developed Test (CMV-PCR-LDT)
  6. Subjects must be candidates for, and will be treated with ganciclovir and/or valganciclovir antiviral therapy.

Exclusion Criteria:

  1. Subjects wherein the HIV status is positive.
  2. Specimens with less than 1.0 ml EDTA plasma for artus testing.
  3. Subjects from whom samples were collected, handled and/or stored inappropriately and/or determined to be unsatisfactory for processing/testing with the artus CMV RG PCR test (for which an explanation is provided in the case of subject exclusion).

    EDTA plasma specimens that have been stored inappropriately which include the following storage conditions: whole blood that has been frozen; whole blood processed for plasma more than 24 hours after collection; plasma stored at room temperature for more than 24 hours or 4C for more than 5 days at -20C for more than 6 months; frozen plasma with more than two freeze thaw cycles;

    Extracted nucleic acid that has been stored inappropriately which include the following storage conditions: extracted DNA stored for more than 5 days at -20C, or longer than six months at -20C; frozen nucleic acid with more than two freeze/thaw cycles.

  4. Specimens that have been stored inappropriately for testing with that test used by the site to demonstrate a CMV infection. (A site specific memo will be provided to QIAGEN on appropriate specimen storage conditions.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034709

Locations
United States, California
University of California - Los Angeles
Los Angeles, California, United States, 90024
United States, Florida
University of Miami
Miami, Florida, United States, 33136
LifeLink Health Care Institute
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
QIAGEN Gaithersburg, Inc
  More Information

Additional Information:
Publications:

Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT01034709     History of Changes
Other Study ID Numbers: C09-CMV-001
Study First Received: December 15, 2009
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by QIAGEN Gaithersburg, Inc:
Cytomegalovirus
CMV

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 31, 2014