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Fever and Neutropenia in Pediatric Oncology Patients

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ClinicalTrials.gov Identifier: NCT03768869
Recruitment Status : Active, not recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fever Neutropenia Drug: Low Risk: Oupatient Management Drug: Low Risk: Inpatient Management Drug: High Risk: Inpatient Management Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Supportive Care
Official Title: Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
Actual Study Start Date : February 2006
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Fever

Arm Intervention/treatment
Experimental: Low Risk: Oupatient Management
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.
Drug: Low Risk: Oupatient Management
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.
Other Name: Oral Antibiotics

Active Comparator: Low Risk: Inpatient Management
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.
Drug: Low Risk: Inpatient Management
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
Other Name: IV Antibiotics

Active Comparator: High Risk: Inpatient Management
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.
Drug: High Risk: Inpatient Management
Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
Other Name: IV Antibiotics, High Risk




Primary Outcome Measures :
  1. Low Risk Treatment [ Time Frame: 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

  2. Protein Evaluation [ Time Frame: 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

  3. Genomics Evaluation [ Time Frame: 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 :
  1. Cost Benefit Analysis [ Time Frame: 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.

  2. Protein Evaluation [ Time Frame: 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.

  3. Genomics Evaluation [ Time Frame: 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768869


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Kelly Maloney, MD Children's Hospital Colorado

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03768869     History of Changes
Other Study ID Numbers: 05-0300.cc
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Pediatrics
Oncology
Outpatient therapy

Additional relevant MeSH terms:
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Fever
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents