Ofloxacin versus trimethoprim-sulfamethoxazole for prevention of infection in patients with acute leukemia and granulocytopenia.

In a prospective randomized study we evaluated the efficacy and safety of oral ofloxacin (dosage: 200 mg three times daily) versus trimethoprim-sulfamethoxazole (dosage: 960 mg three times daily) as antibacterial prophylaxis in 128 patients with acute leukemia who received aggressive cytotoxic chemotherapy and were granulocytopenic for a median duration of 30 days. Fewer patients receiving ofloxacin were colonized by Enterobacteriaceae (13% versus 90%, p less than 0.001) and Pseudomonas aeruginosa (3% versus 14%, p = 0.025), and developed gram-negative bacterial infection (4% versus 26%, p = 0.002), whereas the incidence of gram-positive bacterial (19% versus 22%) and fungal (7% versus 14%) infections was similar in both groups. Ofloxacin was significantly better tolerated than trimethoprim-sulfamethoxazole, and shortened the duration of fever (p = 0.02) and of parenteral antimicrobial therapy for presumed or documented acquired infection (p = 0.01). Ofloxacin appears to be a safe, effective, well-tolerated alternative to trimethoprim-sulfamethoxazole for preventing gram-negative infection in acute leukemia, but more effective prophylaxis of gram-positive infections is still needed.