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

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.

Conditions

• Fever
• Neutropenia
• Cancer

Interventions

DRUG

ciprofloxacin and amoxicillin

PROCEDURE

Outpatient management

DRUG

i.v. antibiotics

PROCEDURE

inpatient management

Sponsors & Collaborators

• Swiss Cancer League

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Swiss Pediatric Oncology Group

  lead OTHER

Principal Investigators

• Roland A Ammann, MD · Pediatric Hematology/Oncology, University Children's Hospital, Inselspital, CH-3010 Bern, Switzerland

• Christoph Aebi, MD · University Children's Hospital, Bern, Switzerland

• Maja Beck-Popovic, MD · Pediatric Hematology/Oncology, University Children's Hospital, Lausanne, Switzerland

• Eveline SJM de Bont, MD · Pediatric Hematology/Oncology, University Children's Hospital, Groningen, The Netherlands

• Thomas Kuehne, MD · Pediatric Hematology/Oncology, University Children's Hospital, Basel, Switzerland

• David Nadal, MD · University Children's Hospital, Zurich

• Felix Niggli, MD · Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland

• Arne Simon, MD · Pediatric Hematology/Oncology, University Children's Hospital, Bonn, Germany

• Nicole Bodmer, MD · Pediatric Hematology/Oncology, University Children's Hospital, Zurich, Switzerland

• Hulya Ozsahin, MD · Pediatric Hematology/Oncology, University Children's Hospital, Geneva, Switzerland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2007-12-31

Completion

2007-12-31

Countries

• Germany
• Netherlands
• Switzerland

Study Locations