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Fever and Neutropenia in Pediatric Oncology Patients

NCT03768869 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-04-27

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kelly Maloney, MD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-04-03
Completion
2009-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768869 on ClinicalTrials.gov