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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of

‣ Acute myeloid leukemia (AML) or acute lymphoblastic leukaemia (ALL) in dose-intensive phases of induction/re-induction, intensification or consolidation or

⁃ ALL or acute lymphoblastic lymphoma patients on a TOT17 protocol or

⁃ Any disease within 100 days of allogeneic or autologous HSCT

• Neutropenia (\<500 cells/mm3)

• Afebrile (temperature \<38.0°C) period for at least 48 hours and no more than 96 hours after at least one temperature measured by axillary or tympanic thermometer (≥38.0°C)

• Commenced on empiric FN antibiotics (any of piperacillin-tazobactam, cefepime, ceftazidime or vancomycin and ciprofloxacin)

Locations
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Contact Information
Primary
Alannah Rudkin
alannah.rudkin@mcri.edu.au
03 8341 6200
Backup
Coen Butters
coen.butters@gmail.com
Time Frame
Start Date: 2021-11-15
Estimated Completion Date: 2026-08
Participants
Target number of participants: 312
Treatments
Experimental: Early Stopping
Stopping empiric FN antibiotics after resolution of fever for 48 hours, irrespective of absolute neutrophil count (ANC)
Active_comparator: Standard of care
Continuing empiric FN antibiotics until resolution of fever for 48 hours and recovery of ANC as defined by the treating clinician but usually to ≥200-500/mm3
Sponsors
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov