Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Age Range:2 - 17
Start Date:March 2007
Contact:Steve Kleiboeker
Phone:(800) 305-5198

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Serial Monitoring of Adenovirus and Fungal Load by Real-Time, Quantitative Polymerase Chain Reaction (PCR) Assay and Correlation With Outcomes in Pediatric Hematopoietic Stem Cell Transplant Patients

This study is designed to determine the rate at which stem cell transplant patients can
develop infection caused by a group of viruses, known as adenovirus, and common fungi. Stem
cells are unspecialized cells, capable of producing more stem cells or other specialized
cells, and are used to replace damaged or diseased cells. The study will be conducted in
children (2-17years old) being transplanted with stem cells from a donor. Patients
undergoing stem cell transplantation are more likely to develop infections as their immune
systems are weakened. Blood, stool, urine and throat swab samples will be collected (for at
least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus.
Subjects will participate for up to 1 year following the transplant procedure.

This study is a multi-center observational study to determine the usefulness of real time
PCR in the detection of adenovirus and fungal infections in patients following HSCT.
Quantitative viral load monitoring will be evaluated to establish correlation with clinical
symptoms and to measure the effectiveness of the therapeutic interventions. Samples will be
collected prior to HSCT and on a scheduled weekly basis for 100 days post-HSCT and after
that when patients show signs of infection. Patients' signs and symptoms and outcomes will
be recorded for correlation with viral load. In addition, viral cultures will be performed
on the same schedule as PCR assay using 3 samples (throat swab, stool, and urine). The study
will be conducted at approximately 6 centers in the United States.

Inclusion Criteria:

1. Pediatric patients greater than or equal to 2 years of age.

2. Allogeneic HSCT.

3. Willing and able to give signed informed consent, or have a legally authorized
representative who is willing to give consent. Informed assent will be required for
children <18 years of age.

4. Reliable and willing to make themselves available for the duration of the study.

Exclusion Criteria:

1. Autologous transplant patients are not eligible for the study.

2. Patients previously enrolled in the study may not reenroll in the event of a
subsequent HSCT.

3. Pediatric patients less than 2 years of age are not eligible for the study.
We found this trial at
San Antonio, Texas 78229
San Antonio, TX
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
Kansas City, MO
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