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)
1 Year
18 Years
Both
Fever, Neutropenia, Cancer
Trial Information
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
antibiotics.
- 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.
Inclusion Criteria:
- Chemotherapy because of malignancy
- Severe neutropenia (absolute neutrophil count ≤ 0.5x10E9/L)
- Fever (axillary temperature ≥ 38.5°C once or ≥ 38.0°C during ≥ 2 hours)
- Able to swallow oral medication
- Written informed consent from patients and/or parents
Exclusion Criteria:
- Status post myeloablative chemotherapy
- Diagnosis: acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or B-cell
Non-Hodgkin lymphoma
- Bone marrow involvement by malignancy ≥ 25%
- Any comorbidity requiring hospitalization: [1] mean arterial blood pressure < 50 mmHg
(up to 10 years) / < 60 mmHg (older than 10 years); [2] oxygen saturation < 94% at
room air; [3] radiologically defined pneumonia; [4] focal bacterial infection; [5]
blood cultures taken at presentation reported positive at reassessment; [6] need for
inpatient treatment or observation due to any other reason, as judged by the
physician in charge
- Ever shaking chills
- Ever axillary temperature ≥ 39.5°C
- Antibacterial treatment before presentation with fever and neutropenia (except for
prevention against Pneumocystis jiroveci [formerly P. carinii] pneumonia)
- Modification or de novo institution of a prophylaxis against P. jiroveci pneumonia
- Modification or de novo institution of a therapy with G-CSF or GM-CSF.
- Allergy to ciprofloxacin and/or amoxicillin
- Serum creatinine level above the upper limit of normal range
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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%)
Principal Investigator
Roland A Ammann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland
Authority:
Switzerland: Swissmedic
Study ID:
SPOG 2003 FN
NCT ID:
NCT00107081
Start Date:
January 2004
Completion Date:
December 2007
Related Keywords:
- Fever
- Neutropenia
- Cancer
- children
- oral antibiotics
- outpatient treatment
- fever and neutropenia
- Fever
- Neutropenia
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