Trial record 2 of 57 for:    Open Studies | "Adenoviridae Infections"

Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by ViraCor Laboratories.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
ViraCor Laboratories
ClinicalTrials.gov Identifier:
NCT00448994
First received: March 15, 2007
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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
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 ViraCor Laboratories:

Estimated Enrollment: 175
Study Start Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT00448994

Contacts
Contact: Steve Kleiboeker (800) 305-5198

Locations
United States, Missouri
Children's Mercy Hospital Not yet recruiting
Kansas City, Missouri, United States, 64108
United States, Texas
Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
ViraCor Laboratories
  More Information

No publications provided

Responsible Party: Steve Kleiboeker, ViraCor
ClinicalTrials.gov Identifier: NCT00448994     History of Changes
Other Study ID Numbers: 05-0101
Study First Received: March 15, 2007
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by ViraCor Laboratories:
adenovirus, fungal, diagnostics, children

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

ClinicalTrials.gov processed this record on October 23, 2014