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Multicenter quality control evaluation results for dalbavancin , an investigational glycopeptide with potent gram-positive activity



Multicenter quality control evaluation results for dalbavancin , an investigational glycopeptide with potent gram-positive activity



Abstracts of the General Meeting of the American Society for Microbiology 103: A-090



Background: Dalbavancin (formerly BI397) is a novel glycopeptide agent with a spectrum most resembling teicoplanin, but with documented greater potency than either vancomycin (VANCO) or teicoplanin against all important Gram-positive pathogens. Pharmacokinetic results and Phase II clinical trial success supports once-weekly dosing. This report summarizes the results of an eight laboratory quality control (QC) study for dalbavancin. Methods: All broth microdilution tests (M7-A5) using four Mueller-Hinton media lots and QC study designs (M23-A2) followed the National Committee for Clinical Laboratory Standards (NCCLS) documents. QC strains tested against dalbavancin included: Enterococcus faecalis (EF) ATCC 29212, Staphylococcus aureus (SA) ATCC 29213 and Streptococcus pneumoniae (SPN) ATCC 49619. VANCO MICs (160 per QC strain) were used as controls. Results: A total of 320 values were generated per QC organism for each MIC test from the eight laboratories. Proposed three log2 dilution MIC ranges contained 99.7-100.0% of the reported values (0.03-0.12 mug/ml for EF and SA; and 0.008-0.03 mug/ml for SPN). Internal QC using VANCO MICs showed that 100% of the values (1-4 mug/ml for EF, 0.5-2 mug/ml for SA, and 0.12-0.5 mug/ml for SPN) were within the NCCLS published guidelines. Colony counts performed from the broth microdilution trays showed an average inoculum concentration of 3.5X105 CFU/ml. Conclusions: As dalbavancin continues through the clinical trials, these QC guidelines for the broth microdilution test will prove to be valuable for susceptibility test accuracy, since drug's solubility may limit the utility of disk diffusion methods.

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Accession: 035349891

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