TY - JOUR
T1 - Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy
AU - Kern, Winfried V.
AU - Cometta, Alain
AU - De Bock, Robrecht
AU - Langenaeken, John
AU - Paesmans, Marianne
AU - Gaya, Harold
AU - Zanetti, Giorgio
AU - Calandra, Thierry
AU - Glauscr, Michel P.
AU - Crokaert, Françoise
AU - Klastersky, Jean
AU - Skoutelis, Athanasios
AU - Bassaris, Harry
AU - Zinner, Stephen H.
AU - Viscoli, Claudio
AU - Engelhard, Dan
AU - Padmos, Andrew
PY - 1999/7/29
Y1 - 1999/7/29
N2 - 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.
AB - 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.
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U2 - 10.1056/NEJM199907293410502
DO - 10.1056/NEJM199907293410502
M3 - Article
C2 - 10423465
AN - SCOPUS:0033614926
VL - 341
SP - 312
EP - 318
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 5
ER -