Evaluation of the Artus® CMV PCR Test

NCT01034709 | Completed Results

• 1 other identifier: C09-CMV-001
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Cytomegalovirus Infections

Keywords

Cytomegalovirus; CMV

Outcome Measures

Primary Outcomes (1)

• a) CMV Viral Load

  The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subjects wherein the HIV status is positive.
• Specimens with less than 1.0 ml EDTA plasma for artus testing.
• 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.
• 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.)

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (5)

University of California - Los Angeles

Los Angeles, California, 90024, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

LifeLink Health Care Institute

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (11)

• Patel R, Paya CV. Infections in solid-organ transplant recipients. Clin Microbiol Rev. 1997 Jan;10(1):86-124. doi: 10.1128/CMR.10.1.86.

  PMID: 8993860 BACKGROUND

• Humar A, Michaels M; AST ID Working Group on Infectious Disease Monitoring. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006 Feb;6(2):262-74. doi: 10.1111/j.1600-6143.2005.01207.x.

  PMID: 16426310 BACKGROUND

• Greanya ED, Partovi N, Yoshida EM, Shapiro RJ, Levy RD, Sherlock CH, Stephens GM. The role of the cytomegalovirus antigenemia assay in the detection and prevention of cytomegalovirus syndrome and disease in solid organ transplant recipients: A review of the British Columbia experience. Can J Infect Dis Med Microbiol. 2005 Nov;16(6):335-41. doi: 10.1155/2005/679386.

  PMID: 18159516 BACKGROUND

• Kanj SS, Sharara AI, Clavien PA, Hamilton JD. Cytomegalovirus infection following liver transplantation: review of the literature. Clin Infect Dis. 1996 Mar;22(3):537-49. doi: 10.1093/clinids/22.3.537.

  PMID: 8852975 BACKGROUND

• Paya C, Humar A, Dominguez E, Washburn K, Blumberg E, Alexander B, Freeman R, Heaton N, Pescovitz MD; Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2004 Apr;4(4):611-20. doi: 10.1111/j.1600-6143.2004.00382.x.

  PMID: 15023154 BACKGROUND

• Sia IG, Wilson JA, Groettum CM, Espy MJ, Smith TF, Paya CV. Cytomegalovirus (CMV) DNA load predicts relapsing CMV infection after solid organ transplantation. J Infect Dis. 2000 Feb;181(2):717-20. doi: 10.1086/315242.

  PMID: 10669361 BACKGROUND

• Singh N. Cytomegalovirus infection in solid organ transplant recipients: new challenges and their implications for preventive strategies. J Clin Virol. 2006 Apr;35(4):474-7. doi: 10.1016/j.jcv.2005.10.014. Epub 2006 Jan 6.

  PMID: 16406798 BACKGROUND

• Hadaya K, Wunderli W, Deffernez C, Martin PY, Mentha G, Binet I, Perrin L, Kaiser L. Monitoring of cytomegalovirus infection in solid-organ transplant recipients by an ultrasensitive plasma PCR assay. J Clin Microbiol. 2003 Aug;41(8):3757-64. doi: 10.1128/JCM.41.8.3757-3764.2003.

  PMID: 12904387 BACKGROUND

• Humar A, Gregson D, Caliendo AM, McGeer A, Malkan G, Krajden M, Corey P, Greig P, Walmsley S, Levy G, Mazzulli T. Clinical utility of quantitative cytomegalovirus viral load determination for predicting cytomegalovirus disease in liver transplant recipients. Transplantation. 1999 Nov 15;68(9):1305-11. doi: 10.1097/00007890-199911150-00015.

  PMID: 10573068 BACKGROUND

• Humar A, Siegal D, Moussa G, Kumar D. A prospective assessment of valganciclovir for the treatment of cytomegalovirus infection and disease in transplant recipients. J Infect Dis. 2005 Oct 1;192(7):1154-7. doi: 10.1086/444398. Epub 2005 Aug 23.

  PMID: 16136456 BACKGROUND

• Piiparinen H, Helantera I, Lappalainen M, Suni J, Koskinen P, Gronhagen-Riska C, Lautenschlager I. Quantitative PCR in the diagnosis of CMV infection and in the monitoring of viral load during the antiviral treatment in renal transplant patients. J Med Virol. 2005 Jul;76(3):367-72. doi: 10.1002/jmv.20367.

  PMID: 15902704 BACKGROUND

Related Links

• Organ Procurement and Transplant Network

Biospecimen

Retention: SAMPLES WITH DNA

Extracted DNA

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Kevin Modarress, PhD Senior Manager Regulatory Affairs Operations NA, Regulatory Affairs
• Organization: QIAGEN

kevin.modarress@qiagen.com

301-944-7103

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 17, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 20, 2014
• Results First Posted: August 20, 2014

Record last verified: 2014-08

Locations

US (5)