Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001976
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-20
Brief Title:
Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
CMV Real-Time PCR Versus PP65 Antigenemia in Diagnosing Cytomegalovirus Disease in Hematopoietic Stem Cell Transplant Patients
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The tests 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-I-0059 | None | None | None |