title: Re-evaluation of quality control guidelines for gatifloxacin and garenoxacin (BMS284756) when susceptibility testing Haemophilus influenzae and Streptococcus pneumoniae.
abstract: An eight laboratory M23-A2 quality control (QC) study was performed for the re-evaluation of gatifloxacin, a new fluoroquinolone, using disk diffusion tests against Streptococcus pneumoniae ATCC 49619. The study also re-evaluated garenoxacin, a novel investigational des-F(6)-quinolone, using disk diffusion tests against S. pneumoniae ATCC 49619 and broth MIC for Hemophilus influenzae ATCC 49247. The gatifloxacin zone diameter results for S. pneumoniae did not indicate a need for QC range modification (26-34 mm; 98.3% of results); however, the garenoxacin zone diameters did demonstrate a need for a minor modification (1 mm; 26-34 mm; 96.3% of reported results). The broth MIC results for H. influenzae showed that 83.1% of the results were at the upper limit of the current range (0.008 microg/ml) published by the National Committee for Clinical Laboratory Standards (NCCLS). The proposed correction could either be 0.002-0.015 microg/mlor 0.004-0.015 microg/ml, each encompassing 100.0% of reported results (prior and current studies). All MIC results for control drugs, levofloxacin and moxifloxacin (disks) or gatifloxacin and clarithromycin (MIC), were within published NCCLS ranges.
authors.affiliation: The JONES Group/JMI Laboratories, North Liberty, Iowa, USA.
authors.forename: T R
authors.initials: TR
authors.lastname: Anderegg
authors.forename: D J
authors.initials: DJ
authors.lastname: Biedenbach
authors.forename: R N
authors.initials: RN
authors.lastname: Jones
mesh_terms: D000890:Anti-Infective Agents / Q000494:pharmacology*; D024881:Drug Resistance, Bacterial; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D017408:Guidelines as Topic; D006193:Haemophilus influenzae / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D007211:Indoles / Q000494:pharmacology*; D008826:Microbial Sensitivity Tests / Q000592:standards*; D011786:Quality Control; D015363:Quinolones / Q000494:pharmacology*; D012680:Sensitivity and Specificity; D013296:Streptococcus pneumoniae / Q000187:drug effects* / Q000302:isolation & purification
chemical_list: D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D007211:Indoles; D015363:Quinolones; D000077734:Gatifloxacin; C419689:garenoxacin