Cefepime as empirical monotherapy in febrile patients with hematological malignancies and neutropenia: A randomized, single-center phase II trial

The purpose of this phase II trial was to evaluate the efficacy and safety of cefepime monotherapy in patients with neutropenia expected to last more than 7 days. Sixty-nine patients with neutropenia (<0.5x10(9)/I) were rando mized during 94 episodes of fever to receive either cefepime monotherapy (n =76) or combination therapy with trimethoprim/sulfamethoxazole plus amikaci n (TMP/SMZ plus AMI, n=18), A successful response to cefepime was seen in 3 1/76 (41%) episodes, with 10/36 (28%) in microbiologically documented infec tions, 3/4 (75%) in clinically documented infections and 18/36 (50%) in fev er of unknown origin. No patient in either treatment group died due to the presenting infection. One patient in the cefepime group discontinued treatm ent due to a rash, Susceptibility testing of blood isolates by E-test strip showed low MC values to cefepime for most isolates. It is concluded that c efepime monotherapy appeared both safe and effective as empirical therapy i n patients with febrile neutropenia.