Fever and Neutropenia in Pediatric Oncology Patients

Phase 3

Withdrawn

• Conditions: Fever; Neutropenia

• Registration Number: NCT03768869
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2006-02
• Primary Completion: 2009-04-03
• Study Completion: 2009-04-03
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Any pediatric patient age <21 years with an oncology diagnosis who is undergoing therapy and is expected to have treatment related neutropenia.

Exclusion Criteria

1. Any patient who has previously undergone autologous or allogeneic bone marrow transplant will be excluded from study enrollment. If a patient is expected to undergo autologous or allogeneic bone marrow transplant as part of therapy at some point after enrollment in the study he/she will be removed from the study at the start of their bone marrow transplant.
2. Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
3. Patients with a known pregnancy will be excluded.
4. Any patient with an underlying chronic musculoskeletal condition (ie Juvenile rheumatoid arthritis, Systemic lupus erythematosis etc) which may make evaluation for joint toxicity related to quinolone treatment difficult.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low Risk Treatment	Start of study to end of study, up to two years	The response to initial antibiotic management without modification with regards to resolution of the episode of fever and neutropenia, measured through blood cultures
Protein Evaluation	Start of study to end of study, up to two years	Comparison of the level of each protein at the initiation of each episode versus resolution to determine if there is a pattern of proteins that correlates with an infectious outcome, measured using ELISA techniques
Genomics Evaluation	Start of study to end of study, up to two years	A comparison of proven infections between patients with the wild-type and variant forms of each gene studied, taken through DNA specimens

Secondary Outcome Measures

Name	Time	Method
Genomics Evaluation	Start of study to end of study, up to two years	A comparison of the number of episodes of fever and neutropenia per patient and the duration of fever per episode between the wild type and variant forms of each gene, taken through DNA specimens.
Cost Benefit Analysis	Start of study to end of study, up to two years	A cost-benefit analysis between the arms, duration of fever per episode between the arms, and number of admissions or deaths. Medical cost will be obtained through billing records and indirect costs will be estimated through information obtained from the family.
Protein Evaluation	Start of study to end of study, up to two years	Determine trends of protein markers on days 3 and 5 of evaluation, using ELISA techniques.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States