Levofloxacin prevented fever and infection during prolonged chemotherapy-induced neutropenia.

M e t h o d s Design: Randomized placebo-controlled trial. Allocation: {Concealed}†.* Blinding: Blinded {clinicians, patients, data collectors, outcome assessors, data analysts, and data safety and monitoring committee}†.* Follow-up period: Until resolution of neutropenia: median 15 to 19 days in patients with leukemia and 8 days in patients with solid tumors or lymphoma. Setting: 35 centers in Italy. Patients: 760 patients 18 to 75 years of age with acute leukemia (49%), lymphoma (44%), or solid tumors (7%) who were at risk for prolonged neutropenia after chemotherapy. Exclusion criteria included allogeneic stem-cell transplantation and fever or infection at enrollment. Intervention: Oral levofloxacin, 500 mg daily (n = 384), or placebo (n = 376), starting 1 to 3 days before chemotherapy (patients with leukemia) or within 3 days of hematopoietic stem-cell transplantation (patients with solid tumors or lymphoma), and continuing until neutropenia resolved. Outcomes: Fever, infection, and death. Patient follow-up: 675 patients (89%) (mean age 48 y, 55% men). 97% of patients were included in the intention-to-treat analysis for fever and death.