Outpatient therapy with oral ofloxacin for patients with low risk neutropenia and fever - A prospective, randomized clinical trial

BACKGROUND. Hospitalization and treatment with broad-spectrum intravenous a ntibiotics is the standard care for patients with neutropenia and fever. Th is randomized clinical trial evaluated the feasibility and efficacy of ambu latory care with oral ofloxacin for patients with low risk, chemotherapy-in duced neutropenia and fever. METHODS. Patients with solid tumors who were treated with conventional dose chemotherapy, presented with fever (auxiliary temperature >38.5 degrees C on a single occasion) and neutropenia (absolute neutrophil count, <500 celI s/mu L), and met low risk criteria were eligible for this study. They were randomized either to hospitalization and treatment with broad-spectrum intr avenous antibiotics, which consisted of a combination of cefazidime and ami kacin, or to outpatient treatment with oral ofloxacin. The definitions of f ever of unknown origin, clinical and microbiologic infection, success, succ ess with modification, and failure were the usual ones for this type of stu dy. RESULTS. One hundred episodes were randomized, and 95 were evaluable (47 we re randomized to ceftazidime/amikacin and 48 to ofloxacin), Baseline charac teristics, as well as the proportion of patients with microbiologic and cli nical infections, were similar in the two groups. In 91% of episodes in the inpatient group and 89% in the ofloxacin group. patients recovered unevent fully (P = 1; 95% CI for the difference, -0.09 to 0.13), with 2 and 5 patie nts requiring modification of the antibiotics, respectively. Eight percent of episodes in the control group and 10.4% in the experimental group result ed in treatment failure. Eight patients (16%) in the outpatient group exper ienced failure with ambulatory care and were admitted to the hospital. CONCLUSIONS. outpatient oral antibiotic therapy with oral ofloxacin for pat ients with low risk neutropenia and fever is safe and similar in efficacy t o hospitalization and treatment with broad-spectrum parenteral antibiotics. Cancer 1999;85:213-9. (C) 1999 American Cancer Society.