Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia

Summary

This randomised controlled trial will determine the non-inferiority of stopping empiric antibiotics prior to absolute neutrophil count (ANC) recovery (Early Stopping) versus stopping antibiotics upon ANC recovery (Standard of Care/ Late Stopping) , in children with cancer and high-risk febrile neutropenia (FN).

Conditions

• Febrile Neutropenia

Interventions

DRUG

Piperacillin and Tazobactam for Injection

Given if patient has no known allergies, until ANC recovery at 100mg/kg (max 4g) 6 hourly.

DRUG

Cefepime Injection

Given if patient has non life-threatening hypersensitivity (preferred option), until ANC recovery at 50mg/kg (max 2g) 8 hourly.

DRUG

Ceftazidime Injection

If non life-threatening hypersensitivity (second option), given until ANC recovery at 50mg/kg (max 2g) 8 hourly

DRUG

Vancomycin Injection

If life-threatening hypersensitivity given with ciprofloxacin, given until ANC recovery at 15mg/kg (max 500mg) 6 hourly

DRUG

Amikacin Injection

Given until ANC recovery at 18-22.5mg/kg (max 1.5g) daily in combination with other antibiotic/s.

DRUG

Ciprofloxacin

If life-threatening hypersensitivity given with vancomycin, given until ANC recovery at 10 mg/kg (max 400 mg) 12 hourly

DRUG

Piperacillin and Tazobactam for Injection

Given if patient has no known allergies at 100mg/kg (max 4g) 6 hourly, stopping 48 hours post-fever resolution.

DRUG

Cefepime Injection

If non life-threatening hypersensitivity (preferred option) at 50mg/kg (max 2g) 8 hourly, stopping 48 hours post-fever resolution

DRUG

Ceftazidime Injection

If non life-threatening hypersensitivity (second option) at 50mg/kg (max 2g) 8 hourly, stopping 48 hours post-fever resolution

DRUG

Vancomycin Injection

If life-threatening hypersensitivity given with ciprofloxacin at 15mg/kg (max 500mg) 6 hourly, stopping 48 hours post-fever resolution

DRUG

Amikacin Injection

At 18-22.5mg/kg (max 1.5g) daily in combination with other antibiotic/s, stopping 48 hours post-fever resolution

DRUG

Ciprofloxacin

If life-threatening hypersensitivity given with vancomycin at 10 mg/kg (max 400 mg) 12 hourly, stopping 48 hours post-fever resolution

Sponsors & Collaborators

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Gabrielle Haeusler · Murdoch Childrens Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2025-12-17

Completion

2025-12-17

Countries

• Australia

Study Locations