Back to resultsFever and Neutropenia in Pediatric Oncology Patients
Primary Purpose
Fever, Neutropenia
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Low Risk: Oupatient Management
Low Risk: Inpatient Management
High Risk: Inpatient Management
Sponsored by
About this trial
This is an interventional supportive care trial for Fever focused on measuring Pediatrics, Oncology, Outpatient therapy
Eligibility Criteria
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:
- 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.
- Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
- Patients with a known pregnancy will be excluded.
- 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.
Sites / Locations
- Children's Hospital Colorado
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Low Risk: Oupatient Management
Low Risk: Inpatient Management
High Risk: Inpatient Management
Arm Description
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Outcomes
Primary Outcome Measures
Low Risk Treatment
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
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
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
Cost Benefit Analysis
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
Determine trends of protein markers on days 3 and 5 of evaluation, using ELISA techniques.
Genomics Evaluation
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.
Full Information
NCT ID
NCT03768869
First Posted
December 3, 2018
Last Updated
April 23, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03768869
Brief Title
Fever and Neutropenia in Pediatric Oncology Patients
Official Title
Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient data to answer the study question
Study Start Date
February 2006 (Actual)
Primary Completion Date
April 3, 2009 (Actual)
Study Completion Date
April 3, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Neutropenia
Keywords
Pediatrics, Oncology, Outpatient therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be stratified as high risk, where they will receive inpatient management, or low risk, where they will then be randomize to receive inpatient or outpatient management.
Masking
None (Open Label)
Masking Description
Because inpatient management and outpatient management use different treatment methods, blinding is not possible.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Risk: Oupatient Management
Arm Type
Experimental
Arm Description
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Arm Title
Low Risk: Inpatient Management
Arm Type
Active Comparator
Arm Description
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Arm Title
High Risk: Inpatient Management
Arm Type
Active Comparator
Arm Description
Patients will be categorized according to risk of serious bacterial infection per risk stratification system, which is based on demographic, clinical history and physical findings that have been shown to be predictive of risk.
Intervention Type
Drug
Intervention Name(s)
Low Risk: Oupatient Management
Other Intervention Name(s)
Oral Antibiotics
Intervention Description
Intravenous Levaquin initially, then oral dosing. Patient discharged to go home to finish medication cycle after initial 120 minutes observation. Patients will be evaluated daily in the clinic, and his or her temperature must be taken and recorded four times per day. Blood cultures will be drawn at clinic visits.
Intervention Type
Drug
Intervention Name(s)
Low Risk: Inpatient Management
Other Intervention Name(s)
IV Antibiotics
Intervention Description
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
Intervention Type
Drug
Intervention Name(s)
High Risk: Inpatient Management
Other Intervention Name(s)
IV Antibiotics, High Risk
Intervention Description
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
Primary Outcome Measure Information:
Title
Low Risk Treatment
Description
The response to initial antibiotic management without modification with regards to resolution of the episode of fever and neutropenia, measured through blood cultures
Time Frame
Start of study to end of study, up to two years
Title
Protein Evaluation
Description
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
Time Frame
Start of study to end of study, up to two years
Title
Genomics Evaluation
Description
A comparison of proven infections between patients with the wild-type and variant forms of each gene studied, taken through DNA specimens
Time Frame
Start of study to end of study, up to two years
Secondary Outcome Measure Information:
Title
Cost Benefit Analysis
Description
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.
Time Frame
Start of study to end of study, up to two years
Title
Protein Evaluation
Description
Determine trends of protein markers on days 3 and 5 of evaluation, using ELISA techniques.
Time Frame
Start of study to end of study, up to two years
Title
Genomics Evaluation
Description
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.
Time Frame
Start of study to end of study, up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
Patients with a known pregnancy will be excluded.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Maloney, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fever and Neutropenia in Pediatric Oncology Patients
We'll reach out to this number within 24 hrs