Symptoms and General Pathology

Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Rare Diseases

Hyperthermia

Neutropenia

Fever

Body Temperature Changes

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Bacterial Agents

Amoxicillin

Ciprofloxacin

Antibiotics, Antitubercular

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

ciprofloxacin and amoxicillin

Outpatient management

i.v. antibiotics

inpatient management

Roland A Ammann, MD

Christoph Aebi, MD

Maja Beck-Popovic, MD

Eveline SJM de Bont, MD

Thomas Kuehne, MD

David Nadal, MD

Felix Niggli, MD

Arne Simon, MD

Nicole Bodmer, MD

Hulya Ozsahin, MD

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.

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.

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)

Swiss Cancer League

Bayer

GlaxoSmithKline

Swiss Pediatric Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting	NCT00107081	Fever Neutropenia Cancer	ciprofloxacin a... Outpatient mana... i.v. antibiotic... inpatient manag...	1 Year - 18 Years	Swiss Pediatric Oncology Group
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting	NCT00107081	Fever Neutropenia Cancer	ciprofloxacin a... Outpatient mana... i.v. antibiotic... inpatient manag...	1 Year - 18 Years	Swiss Pediatric Oncology Group

Spots Global Cancer Trial Database for inpatient management