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Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

This study has been withdrawn prior to enrollment.
(Method development/validation)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Steven B. Kleiboeker, ViraCor Laboratories Identifier:
First received: March 15, 2007
Last updated: December 8, 2014
Last verified: December 2014
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.

Adenovirus Other Mycoses

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Steven B. Kleiboeker, ViraCor Laboratories:

Primary Outcome Measures:
  • Method development [ Time Frame: 3 years ]

Enrollment: 0
Study Start Date: March 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:
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.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00448994

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Texas
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Steven B. Kleiboeker
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: Steven B. Kleiboeker, VP, Scientific Affairs, ViraCor Laboratories Identifier: NCT00448994     History of Changes
Other Study ID Numbers: 05-0101
Study First Received: March 15, 2007
Last Updated: December 8, 2014

Keywords provided by Steven B. Kleiboeker, ViraCor Laboratories:
adenovirus, fungal, diagnostics, children

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases processed this record on August 21, 2017