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Outpatient therapy with oral ofloxacin for patients with low risk neutropenia and fever: a prospective, randomized clinical trial.

Author(s): Hidalgo M, Hornedo J, Lumbreras C, Trigo JM, Colomer R, Perea S, Gomez C, Ruiz A, Garcia-Carbonero R, Cortes-Funes H

Affiliation(s): Division of Medical Oncology, University Hospital 12 de Octubre, Madrid, Spain.

Publication date & source: 1999-01-01, Cancer., 85(1):213-9.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND: Hospitalization and treatment with broad-spectrum intravenous antibiotics is the standard care for patients with neutropenia and fever. This randomized clinical trial evaluated the feasibility and efficacy of ambulatory care with oral ofloxacin for patients with low risk, chemotherapy-induced neutropenia and fever. METHODS: Patients with solid tumors who were treated with conventional dose chemotherapy, presented with fever (axillary temperature >38 degrees C on 2 occasions or >38.5 degrees C on a single occasion) and neutropenia (absolute neutrophil count, <500 cells/microL), and met low risk criteria were eligible for this study. They were randomized either to hospitalization and treatment with broad-spectrum intravenous antibiotics, which consisted of a combination of cefazidime and amikacin, or to outpatient treatment with oral ofloxacin. The definitions of fever of unknown origin, clinical and microbiologic infection, success, success with modification, and failure were the usual ones for this type of study. RESULTS: One hundred episodes were randomized, and 95 were evaluable (47 were randomized to ceftazidime/amikacin and 48 to ofloxacin). Baseline characteristics, as well as the proportion of patients with microbiologic and clinical infections, were similar in the two groups. In 91% of episodes in the inpatient group and 89% in the ofloxacin group, patients recovered uneventfully (P=1; 95% CI for the difference, -0.09 to 0.13), with 2 and 5 patients requiring modification of the antibiotics, respectively. Eight percent of episodes in the control group and 10.4% in the experimental group resulted in treatment failure. Eight patients (16%) in the outpatient group experienced failure with ambulatory care and were admitted to the hospital. CONCLUSIONS: Outpatient oral antibiotic therapy with oral ofloxacin for patients with low risk neutropenia and fever is safe and similar in efficacy to hospitalization and treatment with broad-spectrum parenteral antibiotics.

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