Fosfomycin - eucast

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5. PharmacodynamicsEnterobacteriaceaefAUC/MIC for bacteriostasis25 (serum)3994 (urine)fAUC/MIC for 2 log reduction -fAUC/MIC from clinical data -CommentsReferences• Patel SS et al. Drugs 1997; 53: 637–56• Bergongne-Berezin. E. Fosfomycin and derivatives. In Antimicrobial Agents. Bryskier (ed). 2005, pp. 972-982.6. Monte Carlo simulations and PK/PD breakpointsNot available.7. Clinical dataData relating susceptibility to outcome for intravenous fosfomycin used alone are not available. When fosfomycin is used in combination with other antibiotics to treatpatients with various Gram-positive and Gram-negative infections including pneumonia and other respiratory infections, osteomyelitis, meningitis, ear, nose, and throatinfections, surgical infections, obstetric and gynecological infections, arthritis, septicemia, peritonitis, cervical lymphadenitis, eye infections, diabetic foot infections andtyphoid fever, cure rates are around 80-85% (Falagas ME et al. Clin Infect Dis 2008; 46: 1069-77).Fosfomycin: Rationale for the EUCAST clinical breakpoints, version 1.0 Page 6 of 8
8. Clinical breakpointsNon-species-relatedbreakpointsThere is insufficient evidence to set non-species-related breakpoints.Species-relatedbreakpointsBreakpoints were based on pharmacokinetic data, microbiological data and clinical experience.For Enterobacteriaceae and Staphylococcus spp. breakpoints are S ≤32 mg/L / R >32 mg/L.Species withoutbreakpointsPseudomonas spp., Acinetobacter spp., Enterococcus spp. Neisseria spp. and anaerobes were considered poor targets for systemic fosfomycintherapy and for that reason did not receive breakpoints.For S. pneumoniae, Haemophilus influenzae and Moraxella catarrhalis there was considered to be insufficient evidence to set breakpoints.Clinical qualificationsFor severe infections fosfomycin is always used in combination with a β-lactam, aminoglycoside, fluoroquinolone or glycopeptide antibiotic.Anecdotal evidence suggests that infections caused by wild type P. aeruginosa isolates (ECOFF WT ≤128 mg/) may be treated withcombinations of fosfomycin and other agents.Dosage Breakpoints apply to a dosage of 4-8 g x 3.Additional commentIn vitro susceptibility testing with fosfomycin requires the addition of glucose-6-phosphate either to the medium or to the disk or gradient strip.For agar or broth microdilution MIC determination the medium should be supplemented with 25 mg/L of glucose-6-phosphate. In addition tofosfomycin, disks for diffusion susceptibility testing should contain 50μg of glucose-6-phosphate and gradient MIC strips should contain 25μg ofglucose-6-phosphate.Fosfomycin: Rationale for the EUCAST clinical breakpoints, version 1.0 Page 7 of 8
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Fosfomycin - eucast

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