Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT03768869
Status:
WITHDRAWN
Last Update Posted:
2021-04-27
First Post:
2018-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fever and Neutropenia in Pediatric Oncology Patients
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient data to answer the study question
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.
Detailed Description:
Outpatient management of patients considered to be at low risk for serious bacterial infection has been explored using risk stratification schema based on clinical parameters. First, patients will be stratified based on a clinical risk stratification schema. Patients stratified to the low risk group will be randomized between treatment using standard inpatient intravenous antibiotic therapy or outpatient antibiotic therapy using primarily an oral regimen. Second, an evaluation of proteins important to the innate immune system will be performed to provide a molecular characterization of episodes based on etiology. Third, single nucleotide polymorphisms in genes important for innate immunity will be evaluated to determine effect of each on infection risk during treatment induced neutropenia. Finally, we will develop a bank of both plasma and DNA specimens correlated with clinical outcomes for future use.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: