1949. Safety and Efficacy of Ambulatory Outpatient Treatment of Febrile Neutropenia in Children With Cancer in Mexico: A Multicenter Randomized Controlled Trial

BACKGROUND: Fever and neutropenia (FN) are frequent complications in children with cancer who receive chemotherapy. Although there is evidence of the efficacy of outpatient treatment, inpatient treatment is the standard of care in Mexico City. We aimed to determine whether sequential parenteral-oral outpatient treatment is non-inferior to intravenous inpatient treatment for children with FN in a middle-income setting. METHODS: Randomized controlled clinical trial in subjects 1 to 18 years old with low-risk FN in three hospitals in Mexico City. After 48 to 72 hours of cefepime inpatient treatment, subjects were eligible to participate if they were afebrile for at least 24 hours, had negative cultures and no source of infection. Subjects were randomly assigned to either continue receiving cefepime (inpatient arm) or start receiving cefixime (outpatient arm). Primary end point was treatment failure define as new onset fever, new source of infection or necessity of change antibiotic. Estimated sample size was 68 FN episodes per group. Parametric and nonparametric statistical analyses were performed for comparisons between groups. RESULTS: Between July 2015 and September 2017, a total of 1,237 episodes of FN were evaluated, of which 469 episodes were eligible. From these, 388 were excluded: 337 due to not meeting the inclusion criteria, eight parents refused to participate, four were evaluated after 72 hours of treatment and three were excluded for other reasons. Of the 117 randomized episodes, 59 were allocated into the outpatient arm and 58 into the inpatient arm. After randomization, demographic and clinical variables did not differ between groups. Treatment failure occurred in 6.9% (4) of patients in the inpatient arm vs. 0% in the outpatient arm (P = 0.05). Failures were associated to influenza B infection, catheter related blood stream infection and fever without a source. Mean duration of antibiotics was 4.6 days [SD (standard deviation) 4.5 days, C.I. 95% 3.5–5.8 days] in the outpatient arm and 4.4 days (SD 2.5 days, CI 95%, 3.7–5.0 days) in the inpatient arm (P = 0.70). CONCLUSION: In our population, outpatient sequential, parenteral-oral treatment with cefixime seems to be as safe and efficacious as parenteral inpatient treatment of low-risk FN episodes. DISCLOSURES: All authors: No reported disclosures.