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Oral Antibiotics for Fever in Low-Risk Neutropenic Patients With Cancer: A Double-Blind, Randomized, Multicenter Trial Comparing Single Daily Moxifloxacin With Twice Daily Ciprofloxacin Plus Amoxicillin/Clavulanic Acid Combination Therapy--EORTC Infectious Diseases Group Trial XV.
MedLine Citation:
PMID:  23358983     Owner:  NLM     Status:  Publisher    
PURPOSEThis double-blind, multicenter trial compared the efficacy and safety of a single daily oral dose of moxifloxacin with oral combination therapy in low-risk febrile neutropenic patients with cancer. PATIENTS AND METHODSInclusion criteria were cancer, febrile neutropenia, low risk of complications as predicted by a Multinational Association for Supportive Care in Cancer (MASCC) score > 20, ability to swallow, and ≤ one single intravenous dose of empiric antibiotic therapy before study drug treatment initiation. Early discharge was encouraged when a set of predefined criteria was met. Patients received either moxifloxacin (400 mg once daily) monotherapy or oral ciprofloxacin (750 mg twice daily) plus amoxicillin/clavulanic acid (1,000 mg twice daily). The trial was designed to show equivalence of the two drug regimens in terms of therapy success, defined as defervescence and improvement in clinical status during study drug treatment (< 10% difference).ResultsAmong the 333 patients evaluated in an intention-to-treat analysis, therapy success was observed in 80% of the patients administered moxifloxacin and in 82% of the patients administered combination therapy (95% CI for the difference, -10% to 8%, consistent with equivalence). Minor differences in tolerability, safety, and reasons for failure were observed. More than 50% of the patients in the two arms were discharged on protocol therapy, with 5% readmissions among those in either arm. Survival was similar (99%) in both arms. CONCLUSIONMonotherapy with once daily oral moxifloxacin is efficacious and safe in low-risk febrile neutropenic patients identified with the help of the MASCC scoring system, discharged early, and observed as outpatients.
Winfried V Kern; Oscar Marchetti; Lubos Drgona; Hamdi Akan; Mickel Aoun; Murat Akova; Robrecht de Bock; Marianne Paesmans; Claudio Viscoli; Thierry Calandra
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-28
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  -     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Winfried V. Kern, Universitätsklinikum Freiburg, Freiburg, Germany; Oscar Marchett, Thierry Calandra, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland; Lubus Drgona, National Cancer Institute and Comenius University, Bratislava, Slovakia; Hamdi Akan, Cebeci Hospital, Ankara University; Murat Akova, Hacettepe University Hospital, Ankara, Turkey; Marianne Paesmans, Institut Jules Bordet, Brussels; Robrecht de Bock, Algemeen Ziekenhuis Middelheim, Antwerpen, Belgium; and Claudio Viscoli, San Martino General Hospital, University of Genova, Genova, Italy.
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