Randomized, double-blind, multicenter trial comparing clinafloxacin with imipenem as empirical monotherapy for febrile granulocytopenic patients.
In a double-blind, multicenter trial, 541 febrile granulocytopenic patients were randomized to receive either intravenous (iv) clinafloxacin (200 mg every 12 h) or i.v. imipenem (500 mg every 6 h) as empirical monotherapy. More baseline pathogens were susceptible to clinafloxacin (259 [99%] of 262 organisms) than to imipenem (253 [95%] of 265; P=.03). Initial favorable clinical response rates for clinafloxacin (88 [32%] of 272 patients) and imipenem (89 [33%] of 269) were similar. After addition of other antimicrobial agents, overall response rates were 259 (95%) of 272 for clinafloxacin and 251 (93%) of 269 for imipenem. During the study, only 13 clinafloxacin (5%) and 18 imipenem (7%) recipients died. Both drugs were generally well tolerated. Drug-related skin rash occurred more often with clinafloxacin (11% vs. 6%; P=.07), whereas nausea (2% vs. 5%; P=.16), Clostridium-difficile-associated diarrhea (3% vs. 8%; P=.02), and seizures (0% vs. 2%; P=.06) occurred more often with imipenem. These results suggest that clinafloxacin and imipenem have similar efficacy as empirical monotherapy in febrile granulocytopenic patients.
Winston
D J
DJ
Division of Hematology-Oncology, Department of Medicine, University of California Los Angeles Medical Center, Los Angeles, CA, USA.
Lazarus
H M
HM
Beveridge
R A
RA
Hathorn
J W
JW
Gucalp
R
R
Ramphal
R
R
Chow
A W
AW
Ho
W G
WG
Horn
R
R
Feld
R
R
Louie
T J
TJ
Territo
M C
MC
Blumer
J L
JL
Tack
K J
KJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000380:Agranulocytosis / Q000188:drug therapy* / Q000382:microbiology; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001772:Blood Cell Count; D002170:Canada; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D015378:Imipenem / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D013845:Thienamycins / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D013845:Thienamycins; D015378:Imipenem; C057477:clinafloxacin