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Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

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ClinicalTrials.gov Identifier: NCT00448994
Recruitment Status : Withdrawn (Method development/validation)
First Posted : March 19, 2007
Last Update Posted : December 9, 2014
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Steven B. Kleiboeker, ViraCor Laboratories

Brief Summary:
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.

Condition or disease
Adenovirus Other Mycoses

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.

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : March 2007
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds
U.S. FDA Resources




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


Information from the National Library of Medicine

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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
Pediatric
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448994


Locations
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)

Responsible Party: Steven B. Kleiboeker, VP, Scientific Affairs, ViraCor Laboratories
ClinicalTrials.gov Identifier: NCT00448994     History of Changes
Other Study ID Numbers: 05-0101
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Mycoses
Adenoviridae Infections
DNA Virus Infections
Virus Diseases