Randomized, double-blind, multicenter trial comparing clinafloxacin with imipenem as empirical monotherapy for febrile granulocytopenic patients

D. J. Winston, H. M. Lazarus, R. A. Beveridge, J. W. Hathorn, Rasim A. Gucalp, R. Ramphal, A. W. Chow, W. G. Ho, R. Horn, R. Feld, T. J. Louie, M. C. Territo, J. L. Blumer, K. J. Tack

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)381-390
Number of pages10
JournalClinical Infectious Diseases
Volume32
Issue number3
DOIs
StatePublished - 2001
Externally publishedYes

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Imipenem
Multicenter Studies
Fever
Clostridium difficile
Anti-Infective Agents
clinafloxacin
Exanthema
Pharmaceutical Preparations
Nausea
Diarrhea
Seizures

ASJC Scopus subject areas

  • Immunology

Cite this

Randomized, double-blind, multicenter trial comparing clinafloxacin with imipenem as empirical monotherapy for febrile granulocytopenic patients. / Winston, D. J.; Lazarus, H. M.; Beveridge, R. A.; Hathorn, J. W.; Gucalp, Rasim A.; Ramphal, R.; Chow, A. W.; Ho, W. G.; Horn, R.; Feld, R.; Louie, T. J.; Territo, M. C.; Blumer, J. L.; Tack, K. J.

In: Clinical Infectious Diseases, Vol. 32, No. 3, 2001, p. 381-390.

Research output: Contribution to journalArticle

Winston, DJ, Lazarus, HM, Beveridge, RA, Hathorn, JW, Gucalp, RA, Ramphal, R, Chow, AW, Ho, WG, Horn, R, Feld, R, Louie, TJ, Territo, MC, Blumer, JL & Tack, KJ 2001, 'Randomized, double-blind, multicenter trial comparing clinafloxacin with imipenem as empirical monotherapy for febrile granulocytopenic patients', Clinical Infectious Diseases, vol. 32, no. 3, pp. 381-390. https://doi.org/10.1086/318500
Winston, D. J. ; Lazarus, H. M. ; Beveridge, R. A. ; Hathorn, J. W. ; Gucalp, Rasim A. ; Ramphal, R. ; Chow, A. W. ; Ho, W. G. ; Horn, R. ; Feld, R. ; Louie, T. J. ; Territo, M. C. ; Blumer, J. L. ; Tack, K. J. / Randomized, double-blind, multicenter trial comparing clinafloxacin with imipenem as empirical monotherapy for febrile granulocytopenic patients. In: Clinical Infectious Diseases. 2001 ; Vol. 32, No. 3. pp. 381-390.
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