Fever and Neutropenia in Pediatric Oncology Patients

NCT03768869 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 05-0300.cc
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever; Neutropenia

Keywords

Pediatrics; Oncology; Outpatient therapy

Outcome Measures

Primary Outcomes (3)

• 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

  Start of study to end of study, up to two years

• 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

  Start of study to end of study, up to two years

• Genomics Evaluation

  A comparison of proven infections between patients with the wild-type and variant forms of each gene studied, taken through DNA specimens

  Start of study to end of study, up to two years

Secondary Outcomes (3)

• Cost Benefit Analysis

  Start of study to end of study, up to two years

• Protein Evaluation

  Start of study to end of study, up to two years

• Genomics Evaluation

  Start of study to end of study, up to two years

Study Arms (3)

Low Risk: Oupatient Management

EXPERIMENTAL

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

Low Risk: Inpatient Management

ACTIVE COMPARATOR

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

High Risk: Inpatient Management

ACTIVE COMPARATOR

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

Interventions

Low Risk: Oupatient Management DRUG

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.

Also known as: Oral Antibiotics

Low Risk: Oupatient Management

Low Risk: Inpatient Management DRUG

Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.

Also known as: IV Antibiotics

Low Risk: Inpatient Management

High Risk: Inpatient Management DRUG

Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.

Also known as: IV Antibiotics, High Risk

High Risk: Inpatient Management

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Fever; Neutropenia; Neoplasms

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Kelly Maloney, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because inpatient management and outpatient management use different treatment methods, blinding is not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 7, 2018
• Study Start: February 1, 2006
• Primary Completion: April 3, 2009
• Study Completion: April 3, 2009
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)