Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448994
Status:
WITHDRAWN
Last Update Posted:
2014-12-09
First Post:
2007-03-15
Brief Title:
Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients
Sponsor:
Steven B Kleiboeker
Organization:
ViraCor Laboratories
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Method developmentvalidation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infections caused by adenovirus or fungus Subjects will participate for up to 1 year following the transplant procedure
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None