Search / Trial NCT00001976

Comparison of Two Test Methods-NASBA and Antigenemia-for Detecting Cytomegalovirus Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jan 20, 2000

Trial Information

Current as of November 04, 2024

Completed

Keywords

Cmv Infection Comparison Observational Cytomegalovirus Rt Pcr

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

  • 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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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