Initial empiric therapy of febrile neutropenia with antibiotic monotherapy. Piperacillin/tazobactam versus imipenem/cilastatin (1994-1996)

BACKGROUND: We aimed at comparing the effectiveness and safety of piperacil lin/tazobactam (PIP-TAZ) versus imipenem/cilastin (IMI) administered as emp iric monotherapy in patients with febrile neutrapenia. PATIENTS AND METHOD: Patients with hematological diseases who were randomly assigned either PIP-TAZ or IMI were enrolled in the study. A sequential st rategy antibiotic therapy addition was applied as long as fever persisted o r microorganisms were isolated at 72 h. Moreover, if bacteriologically unco nfirmed fever persisted after 5-7 days, an antifungal therapy was started. The treatment was considered successful if fever and clinical signs resolve d and/or pathogens were cleared without adding further antibiotics at 72 h. Differences between percentages were analyzed using the chi (2) test. RESULTS: 137 patients were evaluated. The successful response rate of PIP-T AZ after 72 h was similar to IMI (32.2 and 35.2%). The defervescence time w as shorter (3.6 and 4.2 days) and the bacterial response more favourable wi th PIP-TAZ than with IMI, but statistically significant differences were no t reached. The overall response in bath groups was 91%. 18.2% of episodes w ere bacteriologically confirmed. The most frequent isolated microorganism w as Staphylococcus coagulase-negative (48.8%). There was one only case of se ptic shock, within the IMI group, and the overall mortality of the group wa s 8.7%. The occurrence of vomiting in the IMI group was significantly highe r than in the PIP-TAZ group (39.9 and 5.6%; p < 0.0001). CONCLUSIONS: PIP-TAZ is as effective as IMI and it constitutes a good choic e as an initial empiric monotherapy of febrile neutropenia.