Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy

Winfried V. Kern, Alain Cometta, Robrecht De Bock, John Langenaeken, Marianne Paesmans, Harold Gaya, Giorgio Zanetti, Thierry Calandra, Michel P. Glauscr, Françoise Crokaert, Jean Klastersky, Athanasios Skoutelis, Harry Bassaris, Stephen H. Zinner, Claudio Viscoli, Dan Engelhard, Andrew Padmos

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Abstract

Background: Intravenously administered antimicrobial agents have been the standard choice for the empirical management of fever in patients with cancer and granulocytopenia. If orally administered empirical therapy is as effective as intravenous therapy, it would offer advantages such as improved quality of life and lower cost. Methods: In a prospective, open-label, multicenter trial, we randomly assigned febrile patients with cancer who had granulocytopenia that was expected to resolve within 10 days to receive empirical therapy with either oral ciprofloxacin (750 mg twice daily) plus amoxicillin-clavulanate (625 mg three times daily) or standard daily doses of intravenous ceftriaxone plus amikacin. All patients were hospitalized until their fever resolved. The primary objective of the study was to determine whether there was equivalence between the regimens, defined as an absolute difference in the rates of success of 10 percent or less. Results Equivalence was demonstrated at the second interim analysis, and the trial was terminated after the enrollment of 353 patients. In the analysis of the 312 patients who were treated according to the protocol and who could be evaluated, treatment was successful in 86 percent of the patients in the oral-therapy group (95 percent confidence interval, 80 to 91 percent) and 84 percent of those in the intravenous-therapy group (95 percent confidence interval, 78 to 90 percent; P=0.02). The results were similar in percent, respectively; P=0.03), as were the duration of fever, the time to a change in the regimen, the reasons for such a change, the duration of therapy, and survival. The types of adverse events differed slightly between the groups but were similar in frequency. Conclusions: In low-risk patients with cancer who have fever and granulocytopenia, oral therapy with ciprofloxacin plus amoxillin-clavulanate is a effective as intravenous therapy.

Original languageEnglish
Pages (from-to)312-318
Number of pages7
JournalNew England Journal of Medicine
Volume341
Issue number5
DOIs
Publication statusPublished - Jul 29 1999

ASJC Scopus subject areas

  • Medicine(all)

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    Kern, W. V., Cometta, A., De Bock, R., Langenaeken, J., Paesmans, M., Gaya, H., Zanetti, G., Calandra, T., Glauscr, M. P., Crokaert, F., Klastersky, J., Skoutelis, A., Bassaris, H., Zinner, S. H., Viscoli, C., Engelhard, D., & Padmos, A. (1999). Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. New England Journal of Medicine, 341(5), 312-318. https://doi.org/10.1056/NEJM199907293410502