Once-daily oral levofloxacin monotherapy versus piperacillin/tazobactam three times a day: a randomized controlled multicenter trial in patients with febrile neutropenia.
A prospective, randomized, controlled multicenter trial was performed to evaluate the efficacy and safety of once-daily oral monotherapy with 500 mg levofloxacin in comparison with 4.5 g piperacillin/tazobactam 3 times a day in patients with low-risk febrile neutropenia. Low risk was defined by oral temperature > or = 38.5 degrees C on one occasion or > or = 38.0 degrees C twice within 24 hours and granulocytopenia < or = 500/microL for less than 10 days. The primary end point was defined as defervescence after 72 hours followed by at least 7 afebrile days. Secondary end points were overall response, time to defervescence, survival on day 30, and toxicity. Thirty-four episodes were included. Fever of unknown origin accounted for 26 (76.5%) of the episodes, microbiologically defined infection for 5 (14.7%) of the episodes, and clinically defined infection for 3 (8.8%) of the episodes. On an intent-to-treat basis, all episodes were evaluable for the primary end point. Levofloxacin and piperacillin/tazobactam were successful after 72 hours of treatment in 76.5% and 88.3% of the episodes. Overall response was achieved in 94.1% and 100% of the episodes, respectively. One inpatient in the oral treatment group died of septic shock without identification of a causative pathogen. A larger phase III trial is warranted to further evaluate the lack of inferiority of the oral monotherapy regimen versus standard intravenous therapy.
Cornely
Oliver A
OA
Department of Internal Medicine I, Klinikum der Universität zu Köln, Köln, Germany. oliver.cornely@uni-koeln.de
Wicke
Thomas
T
Seifert
Harald
H
Bethe
Ullrich
U
Schwonzen
Martin
M
Reichert
Dietmar
D
Ullmann
Andrew J
AJ
Karthaus
Meinolf
M
Breuer
Kai
K
Salzberger
Bernd
B
Diehl
Volker
V
Fätkenheuer
Gerd
G
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D004198:Disease Susceptibility; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005334:Fever / Q000209:etiology* / Q000628:therapy; D005335:Fever of Unknown Origin / Q000209:etiology / Q000628:therapy; D006801:Humans; D016867:Immunocompromised Host; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy; D009503:Neutropenia / Q000139:chemically induced / Q000150:complications*; D015242:Ofloxacin / Q000008:administration & dosage* / Q000627:therapeutic use; D010397:Penicillanic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010878:Piperacillin / Q000008:administration & dosage* / Q000627:therapeutic use; D011446:Prospective Studies; D012449:Safety; D000078142:Tazobactam; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D064704:Levofloxacin; D010397:Penicillanic Acid; D015242:Ofloxacin; D000078142:Tazobactam; D010878:Piperacillin