Cytomegalovirus InfectionsCMVNCT01034709
Evaluation of the Artus® CMV PCR Test
An observational study of Cytomegalovirus Infections, run by QIAGEN Gaithersburg, Inc at 5 sites in United States.
Trial summary
Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- How many people
- 111 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2009to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects wherein the HIV status is positive.
- Specimens with less than 1.0 ml EDTA plasma for artus testing.
- 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.
- 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.)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Hospital
Atlanta, Georgia, 30322
Indiana University
Indianapolis, Indiana, 46202
University of California - Los Angeles
Los Angeles, California, 90024
University of Miami
Miami, Florida, 33136
LifeLink Health Care Institute
Tampa, Florida, 33606
About this study
Official title: Clinical Evaluation of the Artus® CMV RG PCR Test
Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy.
Read the 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
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus, CMV
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034709
- Sponsor's protocol ID
- C09-CMV-001
- Acronym
- CMV
- Status last verified
- Aug 2014
- First submitted
- 15 Dec 2009
- Last updated
- 20 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 8993860Humar 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.
PubMed 16426310Greanya 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.
PubMed 18159516Kanj 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.
PubMed 8852975Paya 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.
PubMed 15023154Sia 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.
PubMed 10669361Singh 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.
PubMed 16406798Hadaya 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.
PubMed 12904387Humar 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.
PubMed 10573068Humar 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.
PubMed 16136456Piiparinen 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.
PubMed 15902704
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Artus® CMV RG PCR Test
- ClinicalTrials.gov ID
- NCT01034709
- Acronym / sponsor ID
- CMV / C09-CMV-001
- Conditions
- Cytomegalovirus Infections
- Keywords
- Cytomegalovirus, CMV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 20 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with symptomatic CMV infection, who are enrolled in this clinical study, will be monitored during antiviral therapy.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- Subjects wherein the HIV status is positive.
- Specimens with less than 1.0 ml EDTA plasma for artus testing.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
a) CMV Viral Load
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8993860Patel 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.
- Background: PubMed 16426310Humar 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.
- Background: PubMed 18159516Greanya 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.
- Background: PubMed 8852975Kanj 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.
- Background: PubMed 15023154Paya 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.
- Background: PubMed 10669361Sia 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.
- Background: PubMed 16406798Singh 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.
- Background: PubMed 12904387Hadaya 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.
- Background: PubMed 10573068Humar 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.
- Background: PubMed 16136456Humar 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.
- Background: PubMed 15902704Piiparinen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by QIAGEN Gaithersburg, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) CMV Viral Load (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034709, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.