title: Development of gemifloxacin in vitro susceptibility test methods for gonococci including quality control guidelines. The Quality Control Study Group.
abstract: Gemifloxacin (formerly SB-265805 or LB20304a) is a new fluoronapthyridone with documented activity against Gram-positive and -negative organisms. The activity of gemifloxacin was tested against 150 Neisseria gonorrhoeae strains, using reference agar dilution, standardized disk diffusion, and Etest (AB BIODISK, Solna, Sweden) methods. Gemifloxacin was very potent against ciprofloxacin (CIPRO)-susceptible strains (MIC(90,) 0.008 microg/ml) but was significantly less active against the CIPRO-resistant gonococci (MIC(90,) 0.12 microg/ml). Etest and reference agar dilution MIC results showed excellent correlation (r = 0.96), and 98.7% MICs were within +/- one log(2) dilution. Agar dilution MICs were also compared to zone diameters obtained using gemifloxacin 5-microg disks; and complete intermethod categorical agreement (100%) was achieved applying breakpoints proposed as follows: < or =0.25 microg/ml (zone, > or =25 mm) for susceptible and > or =1 microg/ml (zone, < or =21 mm) for resistant. Gemifloxacin MIC and disk diffusion te quality control (QC) ranges were established for N. gonorrhoeae ATCC 49226. Data were collected from > or = seven laboratories, three GC agar medium lots for both agar MICs and disk methods, and two lots each of the 5- and 10-microg disks. The proposed MIC QC range was 0.002 to 0.016 microg/ml and the calculated mm zone ranges (median +/- 0.5x average mm range) for both disks were similar, but contained only 88.1 to 91.9% of participant results. To achieve the acceptable > or = 95% of all study results within range, a 43 to 54 mm limits (5-microg disks) were necessary. The excellent broad-spectrum activity and a low reported adverse effects profile of gemifloxacin shows a potential for treatment of fluoroquinolone-resistant gonorrhea.
authors.affiliation: University of Iowa College of Medicine, Medical Microbiology Division, Department of Pathology, C606 GH, 200 Hawkins Drive, Iowa City, IA 52242, USA. ronald-jones@uiowa.edu
authors.forename: R N
authors.initials: RN
authors.lastname: Jones
authors.forename: M E
authors.initials: ME
authors.lastname: Erwin
mesh_terms: D000890:Anti-Infective Agents / Q000494:pharmacology*; D002939:Ciprofloxacin / Q000494:pharmacology; D015169:Colony Count, Microbial; D024841:Fluoroquinolones; D000077735:Gemifloxacin; D008826:Microbial Sensitivity Tests / Q000379:methods; D009287:Naphthyridines / Q000494:pharmacology*; D009344:Neisseria gonorrhoeae / Q000187:drug effects*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D002939:Ciprofloxacin; D000077735:Gemifloxacin