Clinical trial NCT03768869: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Fever
Neutropenia
Keywords: Pediatrics
Oncology
Outpatient therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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:

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.

Primary outcomes:
measure: Low Risk Treatment
timeFrame: Start of study to end of study, up to two years
measure: Protein Evaluation
timeFrame: Start of study to end of study, up to two years
measure: Genomics Evaluation
timeFrame: Start of study to end of study, up to two years
Secondary outcomes:
measure: Cost Benefit Analysis
timeFrame: Start of study to end of study, up to two years
measure: Protein Evaluation
timeFrame: Start of study to end of study, up to two years
measure: Genomics Evaluation
timeFrame: Start of study to end of study, up to two years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Kelly Maloney, MD
role: PRINCIPAL_INVESTIGATOR
References: