Piperacillin, beta-lactam inhibitor plus gentamicin as empirical therapy of a sequential regimen in febrile neutropenia of pediatric cancer patients

The beta-lactam/betalactamase inhibitor combinations are a good choice for empirical antimicrobial therapy in febrile neutropenic patients, because th eir antibacterial spectra include both gram-negative and gram-positive path ogens. This trial was initiated to assess the efficacy and safety of pipera cillin with the beta-lactam inhibitors sulbactam (PSG group) or tazobactam (PTG group) and gentamicin as initial therapy in febrile neutropenia of ped iatric patients. In a prospective study, 239 episodes of fever and neutrope nia were analyzed for the clinical and microbiological response dependent o n infection etiology and treatment group: 66.5% of episodes were classified as fever of unknown origin (FUO) and 33.5%, as microbiologically or clinic ally documented infections; 19.2% of all episodes were due to bacteremia, p redominantly caused by gram-positive organisms (69.6%). The response to the initial therapy was 55.2% overall and 65.4% in episodes of FUO with a sign ificant higher success rate in the PSG group than in the PTG group (70.1% v s. 52.4%, P=0.039), and 35.0% in documented infections. In episodes with do cumented infection longer duration of fever and antimicrobial therapy was r ecorded than for FUO episodes. Four patients died of causes related to infe ction. Fever relapse occurred in 26 episodes (11.1%), predominantly in pati ents who were still neutropenic. Toxic side effects were minimal. The initi al therapy of piperacillin with sulbactam or tazobactam in combination with gentamicin is well tolerated, and its efficacy is comparable to that of ot her combination therapies or of monotherapy with beta-lactam antibiotics in pediatric neutropenic cancer patients.