Fever and Neutropenia in Pediatric Oncology Patients



Status:Active, not recruiting
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 21
Updated:12/9/2018
Start Date:February 2006
End Date:March 2020

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Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates

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.

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.

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.
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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