Journal Article

Randomized, Double-Blind, Multicenter Trial Comparing Clinafloxacin with Imipenem as Empirical Monotherapy for Febrile Granulocytopenic Patients

Drew J. Winston, Hillard M. Lazarus, Roy A. Beveridge, James W. Hathorn, Rasim Gucalp, Reuben Ramphal, Anthony W. Chow, Winston G. Ho, Ruth Horn, Ronald Feld, Thomas J. Louie, Mary C. Territo, Jeffrey L. Blumer and Kenneth J. Tack

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 32, issue 3, pages 381-390
Published in print February 2001 | ISSN: 1058-4838
Published online February 2001 | e-ISSN: 1537-6591 | DOI: https://dx.doi.org/10.1086/318500
Randomized, Double-Blind, Multicenter Trial Comparing Clinafloxacin with Imipenem as Empirical Monotherapy for Febrile Granulocytopenic Patients

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In a double-blind, multicenter trial, 541 febrile granulocytopenic patients were randomized to receive either intravenous (iv) clinafloxacin (200 mg every 12 h) or iv 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.

Journal Article.  6114 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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