Randomized controlled monocentric comparison of once daily ceftriaxone with tobramycin and cefotaxime three times daily with tobramycin in neutropenic fever

A prospective, randomized, controlled monocentric trial was performed to ev aluate the efficacy and safety of once daily ceftriaxone 2 g plus tobramyci n 5 mg/kg in comparison to cefotaxime 2 g t.i.d. plus tobramycin 5 mg/kg qd in the treatment of neutropenic fever. In cases of fever greater than or e qual to 38.5 degreesC and a neutrophil count below 1000/mul. patients with hematological malignancies were assigned to ceftriaxone or cefotaxime, each with tobramycin. The primary endpoint was defined as defervescence < 37.5 <degrees>C on day 4-6 followed by at least 7 afebrile days. Secondary endpo ints were overall response, defined as defervescence on day 25 and toxicity . There were 160 episodes of 114 patients included. Fever of unknown origin accounted for 79 episodes (51%), microbiologically defined infection for 3 6 (23%), clinically defined infection for 27 (17%), and both clinically and microbiologically defined infection for 14 episodes (9%). On an intent-to- treat basis 156 episodes could be evaluated for the primary endpoint. Ceftr iaxone plus tobramycin and cefotaxime plus tobramycin resulted in a primary response in 46.9% and 45.3%, respectively. Overall response was achieved o n study day 25 in 87.7% and 80%, respectively. No significant difference in toxicity was observed. Once-daily ceftriaxone plus tobramycin was not infe rior to cefotaxime t.i.d. plus tobramycin qd in the empirical treatment of neutropenic fever.