A Prospective Multi-Center Study on Pediatric Patients With Fever in Severe Chemotherapy Induced Neutropenia, Including a Randomized Comparison of Outpatient Management and Oral Antimicrobial Therapy Versus Inpatient Management and Intravenous Antimicrobial Therapy in a Subgroup With Low Risk of Adverse Events (Low-Risk Subgroup Study)
Details on antimicrobial therapy
- At presentation with FN (fever and neutropenia) and during an initial inpatient
observation period of 8 to 22 hours, empirical intravenous broad-spectrum antibiotics
are given. Type and dosage are chosen by the treating physician.
- Patients randomized to continued intravenous antibiotics continue with these
- Patients randomized to oral antibiotics receive a combination of oral ciprofloxacin (25
to 30 mg/kg/day, top dose 1500 mg/day) plus oral amoxicillin (65 to 80 mg/kg/day, top
dose 2250 mg/day), both given in two doses per day.
- In both groups, the study gives guidelines (for certain situations) and rules (for
other situations) when to change and when to stop antibiotics.
Details on clinical and laboratory controls
- During antibiotic therapy, patients are seen daily, either as inpatients or as
outpatients according to randomization. Complete blood counts are performed at least
every second day.
- After stopping antibiotic therapy and until resolution of severe neutropenia (if
applicable), patients are seen every other day, with a complete blood count.
- Patients randomized to outpatient management have the possibility to contact at any
time of the day (and night) a pediatric oncologist in case of problems, in order to
discuss necessity for emergency control and/or rehospitalization.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety: No serious medical complication due to infection (death, treatment in ICU [Intensive Care Unit], potentially life-threatening complication) (non-inferiority-design, limit 3.5%)
Roland A Ammann, MD
Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland
SPOG 2003 FN