CompletedPhase 4

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

Australia55 participantsStarted 2021-11-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis of
✓. 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)

Exclusion criteria

✕. Prolonged febrile neutropenia (documented daily temperature ≥38.0°C for ≥5 days)
✕. Documented positive blood culture since onset of FN episode and prior to randomisation
✕. Documented other infection (microbiologically or clinically documented) requiring antibiotic treatment since onset of FN episode and prior to randomisation
✕. Admitted to the ICU at the time of randomisation
✕. Clinical instability (One or more conscious state, respiratory rate, blood pressure, heart rate or oxygen saturations in MET criteria OR two or more respiratory rate, blood pressure, heart rate or oxygen saturations simultaneously (+/- 4 hrs) in the clinical review criteria in 48 hours prior to randomisation)
✕. Within 28 days of last randomisation

What they're measuring

Unfavourable clinical course occurring during the same period of severe neutropenia

Timeframe: During the same episode of neutropenia, up to 28 days post-enrolment.

Trial details

NCT IDNCT04948463

SponsorMurdoch Childrens Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-17

View on ClinicalTrials.gov More Febrile Neutropenia trials