Cytomegalovirus InfectionNCT00001976
Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
An observational study of Cytomegalovirus Infection and Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate the reliability of a new test called Real-Time Polymerase chain reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course of CMV disease in patients who have recently had a bone marrow transplant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytomegalovirus Infection, Infection
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Feb 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Male or female patients that are 10 years of age or older up to 80 years of age are included.
Patients must be enrolled in a protocol at the NIH Clinical Center that will result in the patient receiving an allogeneic stem cell transplant (A-HSCT).
Patients who have not yet received a pre-transplant chemotherapy and radiation therapy conditioning regimen are eligible.
Patients must not have a negative IgG serologic test for CMV and whose hematopoietic stem cell donor also has a negative IgG serologic test as reported by the Bone Marrow Transplant staff.
Patients must not have documentation of prior cytomegalovirus antigenemia or disease prior to starting the conditioning regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: CMV Real-Time PCR Versus PP65 Antigenemia in Diagnosing Cytomegalovirus Disease in Hematopoietic Stem Cell Transplant Patients
This study will evaluate the reliability of a new test called Real-Time Polymerase chain reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course of CMV disease in patients who have recently had a bone marrow transplant. The test's effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used for this purpose.
CMV is a common virus that is transmitted from person to person by close personal contact. In most healthy people, CVM can remain in the body indefinitely without causing any harm. But, in people with weakened immune systems-including those who have just undergone bone marrow transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are available to treat this infection, however. Optimum treatment depends on early and accurate detection.
Read more
Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase 1, patients will have blood drawn for both RT PCR and antigenemia testing once before the bone marrow transplantation and then weekly for the first 100 days after the transplant. During Phase 2-which begins immediately after the end of phase 1 and continues for one year after the transplant-blood samples for both tests will be drawn up to once a week. The samples for both tests will be collected at the same time and will be taken through a catheter (a thin flexible tube inserted into a vein) that has already been placed for the transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over the course of the 1-year study.
It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV infection and predicting disease development, thus enabling doctors to plan early and effective treatment.
Read the detailed description
Currently, it is the standard of care to use the pp65 antigenemia assay to guide anti-cytomegalovirus therapy in hematopoietic stem cell transplant patients. Nevertheless, over the past two years at our institution, only approximately 10% of antigenemia-positive patients went on to develop overt CMV disease and only 22% of patients with documented clinical CMV disease had a positive antigenemia test in the two weeks prior to diagnosis (data on file).
Recently, a test called CMV Real-Time PCR has been applied to the diagnosis of CMV infection. Preliminary data suggests that this test may be of value in detecting active CMV replication. Thus, it may be able to predict CMV disease and help guide antiviral therapy.
We propose a prospective observational study comparing CMV Real-Time PCR test and pp65 antigenemia. This will be done by taking an extra blood sample (approximately 5 mL) for the CMV Real-Time PCR test from hematopoietic stem cell transplant patients whenever a sample for the pp65 antigenemia test is drawn. No separate venipunctures are anticipated. These samples will be drawn on an approximately weekly basis during the first 100 days post-transplant, as is currently done for the pp65 antigenemia test alone. Additionally, at any time blood is drawn for the pp65 antigenemia test after 100 days, we will also take blood for the CMV Real-Time PCR test, up to one year post-transplant. The results of the CMV Real-Time PCR test will not be used to guide therapy. Overt CMV disease will be identified via real-time chart review and patient interviews by one of the investigators in the study. The primary goal of the study is to evaluate the ability of the CMV Real-Time PCR test to accurately detect active CMV viral proliferation and predict ultimate overt CMV disease as compared to the currently-used pp65 antigenemia test.
- Conditions
- Cytomegalovirus Infection, Infection
- Keywords
- CMV, Infection, Comparison, Observational, Cytomegalovirus, RT-PCR
- Medical subject headings
- Cytomegalovirus Infections, Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2000 (estimated)
- Study startJan 2000
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Enrolment
- 180 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001976
- Sponsor's protocol ID
- 000059
- Other IDs
- 00-I-0059
- Status last verified
- Feb 2003
- First submitted
- 20 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Sable CA, Donowitz GR. Infections in bone marrow transplant recipients. Clin Infect Dis. 1994 Mar;18(3):273-81; quiz 282-4. doi: 10.1093/clinids/18.3.273. No abstract available.
PubMed 8011804Rowe JM, Ciobanu N, Ascensao J, Stadtmauer EA, Weiner RS, Schenkein DP, McGlave P, Lazarus HM. Recommended guidelines for the management of autologous and allogeneic bone marrow transplantation. A report from the Eastern Cooperative Oncology Group (ECOG). Ann Intern Med. 1994 Jan 15;120(2):143-58. doi: 10.7326/0003-4819-120-2-199401150-00008.
PubMed 8256974Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: a randomized double-blind study. Blood. 1996 Nov 15;88(10):4063-71.
PubMed 8916975
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CMV Real-Time PCR Versus PP65 Antigenemia in Diagnosing Cytomegalovirus Disease in Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT00001976
- Acronym / sponsor ID
- 000059
- Conditions
- Cytomegalovirus Infection, Infection
- Keywords
- CMV, Infection, Comparison, Observational, Cytomegalovirus, RT-PCR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2000
- Study completion
- Feb 2003
- First posted
- 21 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the reliability of a new test called Real-Time Polymerase chain reaction (RT PCR) in detecting cytomegalovirus (CMV) in the blood and predicting the course of CMV disease in patients who have recently had a bone marrow transplant. The test's effectiveness will be compared with that of the "pp65 antigenemia assay" now routinely used for this purpose.
CMV is a common virus that is transmitted from person to person by close personal contact. In most healthy people, CVM can remain in the body indefinitely without causing any harm. But, in people with weakened immune systems-including those who have just undergone bone marrow transplant-CMV infection can cause serious, and possibly fatal, complications. Drugs are available to treat this infection, however. Optimum treatment depends on early and accurate detection.
Patients aged 10 to 80 years who are scheduled to undergo bone marrow transplant at the NIH Clinical Center as part of an NIH protocol may be eligible for this 2-phase study. In phase 1, patients will have blood drawn for both RT PCR and antigenemia testing once before the bone marrow transplantation and then weekly for the first 100 days after the transplant. During Phase 2-which begins immediately after the end of phase 1 and continues for one year after the transplant-blood samples for both tests will be drawn up to once a week. The samples for both tests will be collected at the same time and will be taken through a catheter (a thin flexible tube inserted into a vein) that has already been placed for the transplant study. RT PCR testing will require an extra 5 milliliters (1 teaspoon) above what is needed for antigenemia testing, amounting to a maximum of about one-half pint extra over the course of the 1-year study.
It is hoped that the new RT PCR test will prove to be more accurate in detecting CMV infection and predicting disease development, thus enabling doctors to plan early and effective treatment.
Detailed description
Currently, it is the standard of care to use the pp65 antigenemia assay to guide anti-cytomegalovirus therapy in hematopoietic stem cell transplant patients. Nevertheless, over the past two years at our institution, only approximately 10% of antigenemia-positive patients went on to develop overt CMV disease and only 22% of patients with documented clinical CMV disease had a positive antigenemia test in the two weeks prior to diagnosis (data on file).
Recently, a test called CMV Real-Time PCR has been applied to the diagnosis of CMV infection. Preliminary data suggests that this test may be of value in detecting active CMV replication. Thus, it may be able to predict CMV disease and help guide antiviral therapy.
We propose a prospective observational study comparing CMV Real-Time PCR test and pp65 antigenemia. This will be done by taking an extra blood sample (approximately 5 mL) for the CMV Real-Time PCR test from hematopoietic stem cell transplant patients whenever a sample for the pp65 antigenemia test is drawn. No separate venipunctures are anticipated. These samples will be drawn on an approximately weekly basis during the first 100 days post-transplant, as is currently done for the pp65 antigenemia test alone. Additionally, at any time blood is drawn for the pp65 antigenemia test after 100 days, we will also take blood for the CMV Real-Time PCR test, up to one year post-transplant. The results of the CMV Real-Time PCR test will not be used to guide therapy. Overt CMV disease will be identified via real-time chart review and patient interviews by one of the investigators in the study. The primary goal of the study is to evaluate the ability of the CMV Real-Time PCR test to accurately detect active CMV viral proliferation and predict ultimate overt CMV disease as compared to the currently-used pp65 antigenemia test.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8011804Sable CA, Donowitz GR. Infections in bone marrow transplant recipients. Clin Infect Dis. 1994 Mar;18(3):273-81; quiz 282-4. doi: 10.1093/clinids/18.3.273. No abstract available.
- Background: PubMed 8256974Rowe JM, Ciobanu N, Ascensao J, Stadtmauer EA, Weiner RS, Schenkein DP, McGlave P, Lazarus HM. Recommended guidelines for the management of autologous and allogeneic bone marrow transplantation. A report from the Eastern Cooperative Oncology Group (ECOG). Ann Intern Med. 1994 Jan 15;120(2):143-58. doi: 10.7326/0003-4819-120-2-199401150-00008.
- Background: PubMed 8916975Boeckh M, Gooley TA, Myerson D, Cunningham T, Schoch G, Bowden RA. Cytomegalovirus pp65 antigenemia-guided early treatment with ganciclovir versus ganciclovir at engraftment after allogeneic marrow transplantation: a randomized double-blind study. Blood. 1996 Nov 15;88(10):4063-71.
Related trials for Cytomegalovirus Infection
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infection and Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001976, which also lists 3 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 4 Mar 2008.