Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.

Détails

ID Serval
serval:BIB_DA2030D4BFD5
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Oral versus intravenous empirical antimicrobial therapy for fever in patients with granulocytopenia who are receiving cancer chemotherapy. International Antimicrobial Therapy Cooperative Group of the European Organization for Research and Treatment of Cancer.
Périodique
New England Journal of Medicine
Auteur(s)
Kern W.V., Cometta A., De Bock R., Langenaeken J., Paesmans M., Gaya H.
ISSN
0028-4793 (Print)
ISSN-L
0028-4793
Statut éditorial
Publié
Date de publication
1999
Volume
341
Numéro
5
Pages
312-318
Langue
anglais
Notes
Publication types: Clinical Trial ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
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.
Mots-clé
Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Agranulocytosis/drug therapy, Agranulocytosis/etiology, Amikacin/administration & dosage, Amoxicillin/administration & dosage, Antineoplastic Agents/adverse effects, Bacteremia/drug therapy, Bacteremia/mortality, Ceftriaxone/administration & dosage, Child, Child, Preschool, Ciprofloxacin/administration & dosage, Clavulanic Acid/administration & dosage, Drug Therapy, Combination/administration & dosage, Drug Therapy, Combination/adverse effects, Female, Fever/drug therapy, Fever/etiology, Humans, Infusions, Intravenous, Male, Middle Aged, Neoplasms/complications, Neoplasms/drug therapy, Prospective Studies, Survival Rate
Pubmed
Web of science
Création de la notice
25/01/2008 14:31
Dernière modification de la notice
03/03/2018 21:54
Données d'usage