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Previous Volume 341:312-318 July 29, 1999 Number 5 Next

	Full Text PDF Editorial by Finberg, R. W. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

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 the intention-to-treat analysis (80 percent and 77 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 amoxicillin–clavulanate is as effective as intravenous therapy.

Source Information

From the Sektion Infektiologie und Klinische Immunologie, Medizinische Universitätsklinik und Poliklinik, Ulm, Germany (W.V.K.); the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (A.C.); the Allgemeen Ziekenhuis Middelheim, Antwerp, Belgium (R.B.); the Institut Jules Bordet, Brussels, Belgium (J.L., M.P.); and the Royal Brompton Hospital, London (H.G.). Other authors were Giorgio Zanetti, M.D., Thierry Calandra, M.D., and Michel P. Glauser, M.D. (Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland), Françoise Crokaert, M.D., and Jean Klastersky, M.D. (Institut Jules Bordet, Brussels, Belgium), Athanasios Skoutelis, M.D., and Harry Bassaris, M.D. (Patras University Hospital, Patras, Greece), Stephen H. Zinner, M.D. (Brown University, Providence, R.I.), Claudio Viscoli, M.D. (National Institute for Cancer Research, Genoa, Italy), Dan Engelhard, M.D. (Hadassah University Hospital, Jerusalem, Israel), and Andrew Padmos, M.D. (Kingston Regional Cancer Center, Kingston, Ont., Canada).

Address reprint requests to Dr. Kern at the Medizinische Universitätsklinik und Poliklinik, Sektion Infektiologie und Klinische Immunologie, D-89070 Ulm, Germany, or at winfried.kern{at}medizin.uni-ulm.de.

Full Text of this Article

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Extract | Full Text  
N Engl J Med 2000; 342:55-58, Jan 6, 2000. Correspondence

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