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 (<0.5 x 10(9)/1) were randomized during 94 episodes of fever to receive either cefepime monotherapy (n=76) or combination therapy with trimethoprim/sulfamethoxazole plus amikacin (TMP/SMZ plus AMI, n=18). A successful response to cefepime was seen in 31/76 (41%) episodes, with 10/36 (28%) in microbiologically documented infections, 3/4 (75%) in clinically documented infections and 18/36 (50%) in fever of unknown origin. No patient in either treatment group died due to the presenting infection. One patient in the cefepime group discontinued treatment due to a rash. Susceptibility testing of blood isolates by E-test strip showed low MIC values to cefepime for most isolates. It is concluded that cefepime monotherapy appeared both safe and effective as empirical therapy in patients with febrile neutropenia.
Engervall
P
P
Department of Medicine, Karolinska Hospital, Stockholm, Sweden. per@divmed.ks.se
Kalin
M
M
Dornbusch
K
K
Björkholm
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077723:Cefepime; D002511:Cephalosporins / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D019337:Hematologic Neoplasms / Q000150:complications* / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology
D002511:Cephalosporins; D000077723:Cefepime