NCT00107081

Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Swiss Pediatric Oncology Group · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether, in children with cancer presenting with fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral antibiotics in an outpatient setting after an initial phase of intravenous antibiotics and in-hospital observation for 8 to 22 hours, is not inferior as to safety and efficacy compared to continued intravenous antibiotics given in-hospital.

Detailed description

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.

Conditions

• Fever
• Neutropenia
• Cancer

Interventions

Type	Name	Description
DRUG	ciprofloxacin and amoxicillin
PROCEDURE	Outpatient management
DRUG	i.v. antibiotics
PROCEDURE	inpatient management

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-04-05
• Last updated: 2020-11-02

Locations

12 sites across 3 countries: Germany, Netherlands, Switzerland