Evaluation of the Artus® CMV PCR Test

Cytomegalovirus Infections Clinical Trial

— CMV  

Official title:

Clinical Evaluation of the Artus® CMV RG PCR Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034709
• Other study ID #: C09-CMV-001
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: August 1, 2014
• Start date: December 2009
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Indiana University	Indianapolis	Indiana
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	LifeLink Health Care Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2005 Aug 23. — View Citation

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. Review. — View Citation

Patel R, Paya CV. Infections in solid-organ transplant recipients. Clin Microbiol Rev. 1997 Jan;10(1):86-124. Review. — View Citation

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. — View Citation

Piiparinen H, Helanterä I, Lappalainen M, Suni J, Koskinen P, Grönhagen-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. — View Citation

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. — View Citation

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. Epub 2006 Jan 6. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Organ Procurement and Transplant Network