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

PHASE4RecruitingINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

July 31, 2026

Study Completion Date

August 31, 2026

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

Trial Locations (1)

3052

RECRUITING

Royal Children's Hospital, Melbourne

All Listed Sponsors
lead

Murdoch Childrens Research Institute

OTHER