Randomized placebo-controlled trial of oral antibiotics in pediatric oncology patients at low-risk with fever and neutropenia

Abstract

Purpose: Fever combined with neutropenia in pediatric oncology patients has traditionally been managed in the hospital with broad-spectrum intravenous antibiotics until there is documented neutrophil recovery. Recent evidence has suggested that patients at "low-risk" can be discharged from the hospital before neutrophil recovery. Whether oral antibiotics are required at the time of discharge is not known.

Patients and methods: Using a randomized, double-blind, placebo-controlled study design, 73 patients at low-risk with episodes of fever and neutropenia were discharged home while still neutropenic: 37 administered with oral cloxacillin and cefixime and 36 administered with corresponding placebos. Low-risk criteria included: afebrile for more than 24 hours, negative blood culture results at 48 hours, absence of clinical sepsis, cancer in bone marrow remission, and absence of comorbid conditions.

Results: Five patients (14%; 95% confidence interval [CI]; 2%-25%) in the antibiotic arm and two patients (6%; 95% CI; 0%-13%) in the placebo arm were readmitted to the hospital with recurrent fever while still neutropenic (P = 0.43). One patient randomized to the placebo arm had a positive blood culture result on readmission, which responded to appropriate intravenous antibiotics. All of the readmissions were uneventful and there were no fatalities. The average cost per episode of fever and neutropenia was $1,821 Canadian dollars with only minimal incremental cost to the antibiotic arm.

Conclusion: This study supports the discontinuation of antibiotics in pediatric oncology patients at low-risk who still have neutropenia at the time of discharge from the hospital.