Fever and Neutropenia in Pediatric Oncology Patients

• Status: Withdrawn
• Trial end date: 2009-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

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.