Clinical trial · Interventional
Fever and Neutropenia in Pediatric Oncology Patients
Fever and Neutropenia in Pediatric Oncology Patients: A Randomized, Controlled, Multi-Center Study of Outpatient Therapy Evaluation of Genomic and Proteomic Correlates
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient data to answer the study question
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Risk: Inpatient Management | Drug | — | UNRESOLVED |
| Low Risk: Inpatient Management | Drug | — | UNRESOLVED |
| Low Risk: Oupatient Management | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low Risk: Oupatient Management
- description
- 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.
- interventionNames
- Drug: Low Risk: Oupatient Management
- type
- ACTIVE_COMPARATOR
- label
- Low Risk: Inpatient Management
- description
- 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.
- interventionNames
- Drug: Low Risk: Inpatient Management
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available