Nitroxoline Rationale for the NAK clinical breakpoints, version th October 2013
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1 Nitroxoline Rationale for the NAK clinical breakpoints, version th October 2013 Foreword NAK The German Antimicrobial Susceptibility Testing Committee (NAK - Nationales Antibiotika-Sensitivitätstest -Komitee; German NAC) was founded the 14th of June, Major objectives are I) to establish EUCAST breakpoints and technical aspects of in vitro antimicrobial susceptibility testing in German laboratories, II) to adapt EUCAST breakpoint to local requirements, and (III) to evaluate breakpoints for antimicrobial agents that have not yet been considered by EUCAST. The organizational structure largely follows that of EUCAST. The General Committee comprising representatives of national scientific societies and organizations in the fields of infectious diseases and patient safety decides on recommendations proposed by the Steering Committee. The Steering Committee currently consists of 14 experts having a background in clinical microbiology, infectious diseases or regulatory affairs. Both boards will meet at least once a year. Industry has an observational status only. Information on NAK is available on the NAK website at NAK rationale documents NAK rationale documents summarise the information on which the NAK clinical breakpoints are based. Availability of NAK document All NAK documents are freely available from the NAK website at Citation of NAK documents This rationale document should be cited as: NAK - Nationales Antibiotika-Sensitivitätstest -Komitee. Nitroxoline: Rationale for the clinical breakpoints, version 1.0, Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 1 of 12
2 Introduction Nitroxoline (5-nitro-8-hydroxyquinoline) is an oral antibiotic which is different from any other antimicrobial drug class. Following oral administration, the drug is heavily metabolized (>95%) into microbiologically active conjugated and non-conjugated derivatives, resulting in relatively low serum concentrations and high urinary concentrations. The drug is primarily used for oral therapy of acute cystitis. Its antimicrobial spectrum covers Escherichia coli and other uropathogens. Pseudomonas spp. are resistant. The mechanism of action is chelation of divalent cations required for inhibition of RNA polymerase. At sub-inhibitory concentrations the drug inhibits the adhesion of Escherichia coli and other uropathogens to uroepithelial cells. 1. Dosage BSAC CA-SFM CRG DIN NWGA SRGA Most common dose 250mg x 3 Maximum dose schedule 250mg x 3 Available formulations Oral Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 2 of 12
3 2. MIC distributions 1 and epidemiological cut-off (ECOFF) values (mg/l) Organism ECOFF Escherichia coli - Kresken Escherichia coli - Marre Escherichia coli - Opferkuch Escherichia coli - Pfister Escherichia coli Citrobacter spp - Opferkuch Citrobacter spp ND Klebsiella oxytoca - Marre Klebsiella oxytoca - Pfister Klebsiella oxytoca ND Klebsiella pneumoniae - Kresken Klebsiella pneumoniae - Marre Klebsiella pneumoniae - Pfister Klebsiella pneumoniae Klebsiella spp - Opferkuch Klebsiella spp ND Morganella morganii Kresken Morganella morganii - Opferkuch Morganella morganii ND Proteus mirabilis - Kresken Proteus mirabilis - Marre Proteus mirabilis - Opferkuch Proteus mirabilis - Pfister Proteus mirabilis Proteus vulgaris Kresken Proteus vulgaris - Opferkuch Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 3 of 12
4 Organism ECOFF Proteus vulgaris - Pfister Proteus vulgaris ND Serratia spp - Opferkuch Serratia spp ND Enterobacter cloacae - Pfister Enterobacter cloacae ND Enterobacter spp - Marre Enterobacter spp - Opferkuch Enterobacter spp - Pfister Enterobacter spp ND Other Enterobacteriaceae - Pfister Other Enterobacteriaceae ND Acinetobacter spp - Opferkuch Acinetobacter spp - Pfister Acinetobacter spp ND Pseudomonas aeruginosa - Marre Pseudomonas aeruginosa - Pfister Pseudomonas aeruginosa ND Pseudomonas spp - Opferkuch Pseudomonas spp ND Staphylococcus aureus - Marre Staphylococcus aureus - Opferkuch Staphylococcus aureus - Pfister Staphylococcus aureus ND Staphylococcus epidermidis - Opferkuch Staphylococcus epidermidis ND CNS - Marre CNS - Pfister CNS ND Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 4 of 12
5 Organism ECOFF Staphylococcus saprophyticus - Kresken Staphylococcus saprophyticus - Marre Staphylococcus saprophyticus Enterococcus faecalis - Opferkuch Enterococcus faecalis - Pfister Enterococcus faecalis ND Enterococcus faecium - Pfister Enterococcus faecium ND Enterococcus spp - Marre Enterococcus spp ND Streptococcus spp - Pfister Streptococcus spp ND Haemolytic streptococci - Opferkuch Haemolytic streptococci ND 1 The table includes MIC distributions available at the time breakpoints were set. They represent combined distributions from multiple sources and time periods. The distributions are used to define the epidemiological cut-offs (ECOFF) and give an indication of the MICs for organisms with acquired or mutational resistance mechanisms. They should not be used to infer resistance rates. When there is insufficient evidence (IE) no epidemiological cut-off has been determined (ND). Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 5 of 12
6 3. Breakpoints prior to harmonisation (mg/l) S< / R> General breakpoints Species-related breakpoints Enterobacteriaceae Pseudomonas spp. Acinetobacter spp. Staphylococcus spp. Streptococcus spp. Streptococcus pneumoniae Enterococcus spp. Haemophilus influenzae Moraxella catarrhalis Corynebacteria Neisseria meningitidis Neisseria gonorrhoeae Pasteurella multocida Anaerobes, Gram-positive Anaerobes, Gram-negative Campylobacter spp. Helicobacter pylori *breakpoints published in 2013 BSAC CA-SFM CRG DIN NWGA SRGA CLSI <1 / >32* Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 6 of 12
7 4. Pharmacokinetics Dosage (mg) 200 mg single dose orally 200 mg x 3 orally 250 mg x 3 orally Cmax (mg/l) HPLC 5.59 ± 3.15 after 1.75 ± 1.04 h 8.08 ± 4.42 after 1 h Mean: 3.5 after 3 h Cmin (mg/l) Total body clearance (L/h) T ½ (h), mean (range) 2.63 ± 2.66 ca. 2 AUC24h (mg.h/l) ± Fraction unbound (%) 90 Volume of distribution (L/KG) Comments Two values are given where references differ. Cells are left empty when data are not readily available. Oral absorption is almost 100%. Concentration in urine >200 mg/l (bioassay) References Bergogne-Berezin et al Path Biol 1987; 35: Nitroxolin forte Fachinformation (SPC), March 2012 Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 7 of 12
8 5. Pharmacodynamics Dose fauc/mic for bacteriostasis fauc/mic for 2 log reduction fauc/mic from clinical data Comments Pharmacodynamics parameters for nitroxoline have not been determined. Cells are left empty when data are not readily available. Nitroxoline usually exerts bacteriostatic activity. Urinary inhibitory titers of nitroxoline for E. coli, K. pneumoniae and S. saprophyticus were higher at ph 5.5 than at ph 8.0. References Wagenlehner et al (manuscript submitted to Antimicrob Agents Chemother) Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 8 of 12
9 6. Monte Carlo simulations and Pk/Pd breakpoints No data Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 9 of 12
10 7. Clinical data Efficacy of nitroxoline has been in clinical trials for treatment of patients with acute cystitis and acute recurrent cystitis caused by bacteria categorized as wildtype (unpublished data, see attachment). Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 10 of 12
11 8. Clinical breakpoints Non-species-related breakpoints Species-related breakpoints Species without breakpoints Clinical qualifications There is insufficient evidence to set a non-species related breakpoint. For E. coli, K. pneumoniae, P. mirabilis and S. saprophyticus the breakpoint is 16/32 mg/l. All other species and bacterial groups. Nitroxoline is used for prophylaxis and treatment of acute or recurrent uncomplicated UTI. Dosage The breakpoint applies to a daily oral dose of 250 mg x 3. Additional comment Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 11 of 12
12 9. Agent name - NAK clinical MIC breakpoints These can be found at Nitroxoline: Rationale for the NAK clinical breakpoints, version 1.0 Page 12 of 12
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