scholarly journals Determination of MIC Quality Control Ranges for the Novel Gyrase Inhibitor Zoliflodacin

2019 ◽  
Vol 57 (9) ◽  
Author(s):  
Alita A. Miller ◽  
Maria M. Traczewski ◽  
Michael D. Huband ◽  
Patricia A. Bradford ◽  
John P. Mueller
Keyword(s):  
Quality Control ◽  
Susceptibility Testing ◽  
The Novel ◽  
Tier 2 ◽  
Phase 3 ◽  
Content Type ◽  
Surveillance Studies ◽  
Agar Dilution

ABSTRACT This report describes the results of two different, multilaboratory quality control (QC) studies that were used to establish QC ranges for the novel gyrase inhibitor zoliflodacin against the ATCC strains recommended by the Clinical and Laboratory Standards Institute (CLSI). Following the completion of an eight-laboratory, CLSI document M23-defined tier 2 study, the agar dilution MIC QC range for zoliflodacin against the Neisseria gonorrhoeae QC strain ATCC 49226 was defined as 0.06 to 0.5 μg/ml and was approved by the CLSI Subcommittee on Antimicrobial Susceptibility Testing. This QC range will be used for in vitro susceptibility testing of zoliflodacin during phase 3 human clinical trials and surveillance studies, and eventually it will be implemented in clinical labs. In a separate study, broth microdilution MIC quality control ranges for zoliflodacin against additional QC strains were determined to be 0.12 to 0.5 μg/ml for Staphylococcus aureus ATCC 29213, 0.25 to 2 μg/ml for Enterococcus faecalis ATCC 29212, 1 to 4 μg/ml for Escherichia coli ATCC 25922, 0.12 to 0.5 μg/ml for Streptococcus pneumoniae ATCC 49619, and 0.12 to 1 μg/ml for Haemophilus influenzae ATCC 49247. These MIC QC ranges were also approved by CLSI for use in future in vitro susceptibility testing studies against organisms other than N. gonorrhoeae.

scholarly journals Determination of Disk Diffusion and MIC Quality Control Ranges for Nafithromycin (WCK 4873), a New Lactone-Ketolide

2017 ◽  
Vol 55 (10) ◽  
pp. 3021-3027 ◽  
Author(s):  
Meredith A. Hackel ◽  
James A. Karlowsky ◽  
Dana Dressel ◽  
Daniel F. Sahm
Keyword(s):  
Quality Control ◽  
Susceptibility Testing ◽  
Disk Diffusion ◽  
Tier 2 ◽  
Phase 3 ◽  
Content Type ◽  
Surveillance Studies ◽  
Testing Patient

ABSTRACTDisk diffusion and MIC quality control (QC) ranges were determined for nafithromycin, a new lactone-ketolide, following the completion of a nine-laboratory, Clinical and Laboratory Standards Institute (CLSI) document M23-defined tier 2 study. Five QC strains consistent with the spectrum of activity of nafithromycin were tested:Staphylococcus aureusATCC 25923 (disk only),S. aureusATCC 29213 (broth only),Enterococcus faecalisATCC 29212 (broth only),Streptococcus pneumoniaeATCC 49619 (disk and broth), andHaemophilus influenzaeATCC 49247 (disk and broth). Nafithromycin disk diffusion QC ranges were determined to be 25 to 31 mm forS. aureusATCC 25923, 25 to 31 mm forS. pneumoniaeATCC 49619, and 16 to 20 mm forH. influenzaeATCC 49247. Nafithromycin MIC QC ranges were determined to be 0.06 to 0.25 μg/ml forS. aureusATCC 29213, 0.016 to 0.12 μg/ml forE. faecalisATCC 29212, 0.008 to 0.03 μg/ml forS. pneumoniaeATCC 49619, and 2 to 8 μg/ml forH. influenzaeATCC 49247. All disk diffusion and MIC QC ranges established in this study were approved by the CLSI Subcommittee on Antimicrobial Susceptibility Testing at their June 2015 meeting and were initially reported in the 2017 M100S document. The QC ranges established in this study should be used for determining thein vitroactivity of nafithromycin in phase 2 and phase 3 human clinical trials and subsequently for testing patient isolates and isolates in phase 4 surveillance studies.

scholarly journals Determination of Disk Diffusion and MIC Quality Control Guidelines for Solithromycin, a Novel Fluoroketolide Antibacterial, against Neisseria gonorrhoeae

2015 ◽  
Vol 53 (12) ◽  
pp. 3888-3890 ◽  
Author(s):  
Stefan Riedel ◽  
James E. Ross ◽  
David J. Farrell ◽  
Robert K. Flamm ◽  
Ronald N. Jones
Keyword(s):  
Quality Control ◽  
Susceptibility Testing ◽  
Disk Diffusion ◽  
Control Strain ◽  
Content Type ◽  
Disk Diffusion Testing ◽  
Quality Control Study ◽  
Agar Dilution ◽  
Control Study

This solithromycin quality control study was performed to establish quality control (QC) ranges for theN. gonorrhoeaeATCC 49226 control strain for MIC agar dilution testing (AD) and zones by disk diffusion testing (DD). The following ranges were established: AD, 0.03 to 0.25 μg/ml, and DD, 33 to 43 mm. In January 2015, the CLSI Subcommittee on Antimicrobial Susceptibility Testing approved these ranges, which will be important when evaluating solithromycin against clinical isolates ofN. gonorrhoeae.

scholarly journals Impact of Variations in Test Method Parameters onIn VitroActivity of Surotomycin against Clostridium difficile and Surotomycin Quality Control Limits for Broth Microdilution and Agar Dilution Susceptibility Testing

2015 ◽  
Vol 54 (3) ◽  
pp. 749-753 ◽  
Author(s):  
Maria M. Traczewski ◽  
Jennifer Deane ◽  
Daniel Sahm ◽  
Steven D. Brown ◽  
Laurent Chesnel
Keyword(s):  
Quality Control ◽  
Clostridium Difficile ◽  
Calcium Concentration ◽  
Susceptibility Testing ◽  
Test Method ◽  
Test Parameter ◽  
Content Type ◽  
Parameter Variations ◽  
Agar Dilution ◽  
Control Limits

Test parameter variations were evaluated for their effects on surotomycin MICs. Calcium concentration was the only variable that influenced MICs; therefore, 50 μg/ml (standard for lipopeptide testing) is recommended. Quality control ranges forClostridium difficile(0.12 to 1 μg/ml) andEggerthella lenta(broth, 1 to 4 μg/ml; agar, 1 to 8 μg/ml) were approved by the Clinical and Laboratory Standards Institute based on these data.

scholarly journals EUCAST Determination of Olorofim (F901318) Susceptibility of Mold Species, Method Validation, and MICs

2018 ◽  
Vol 62 (8) ◽  
Author(s):  
Karin Meinike Jørgensen ◽  
Karen M. T. Astvad ◽  
Rasmus Krøger Hare ◽  
Maiken Cavling Arendrup
Keyword(s):  
Fusarium Solani ◽  
Susceptibility Testing ◽  
Wild Type ◽  
Preparation Methods ◽  
Content Type ◽  
Microtiter Plates ◽  
Upper Limits ◽  
Limited Variation

ABSTRACT Olorofim is a novel antifungal agent with in vitro activity against Aspergillus and some other molds. Here, we addressed technical aspects for EUCAST olorofim testing and generated contemporary MIC data. EUCAST E.Def 9.3.1 testing was performed comparing two plate preparation methods (serial dilution in medium [serial plates] versus predilution in DMSO [ISO plates]), two lots of olorofim, visual (visual-MIC) versus spectrophotometer (spec-MIC) reading, and four polystyrene plates using 34 to 53 Aspergillus isolates from five genera. Subsequently, olorofim MICs were compared to itraconazole, voriconazole, posaconazole, and amphotericin B MICs for 298 clinical mold isolates (2016 to 2017). Wild-type upper limits (WT-UL) were determined following EUCAST principles for epidemiologic cutoff value (ECOFF) setting. Olorofim median MICs comparing serial plates and ISO plates were identical (25/36 [69%]) or one dilution apart (11/36 [31%]). Interperson agreement for visual-MICs was 92% to 94%/100% for ≤1/≤2 dilutions, respectively. The visual-MIC values across tested microtiter plates and olorofim lots revealed only discrete differences (≤1 dilution lower for treated plates). No single spec-MIC criterion was applicable to all species. Olorofim MICs were low against 275 Aspergillus species isolates (modal MIC, 0.06 mg/liter; MIC range, < 0.004 to 0.25 mg/liter) and three dermatophytes (MICs 0.03 to 0.06 mg/liter). MICs against Fusarium were diverse, with full inhibition of F. proliferatum (MIC, 0.016), 50% growth inhibition of Fusarium solani at 1 to 2 mg/liter, and no inhibition of F. dimerum. Olorofim displayed potent in vitro activity against most mold isolates and was associated with limited variation in EUCAST susceptibility testing.

scholarly journals In Vitro Activity of Iclaprim against Isolates in Two Phase 3 Clinical Trials (REVIVE-1 and -2) for Acute Bacterial Skin and Skin Structure Infections

2019 ◽  
Vol 63 (4) ◽  
Author(s):  
Stephanie Noviello ◽  
Sophie Magnet ◽  
Stephen Hawser ◽  
David B. Huang
Keyword(s):  
Susceptibility Testing ◽  
In Vitro Activity ◽  
Phase 3 ◽  
Gram Positive ◽  
Two Phase ◽  
Content Type ◽  
Skin Structure ◽  
Streptococcus Anginosus ◽  
Antibacterial Susceptibility

ABSTRACT Iclaprim, a selective bacterial dihydrofolate reductase inhibitor, and other antibiotics were tested against Gram-positive isolates from two phase 3 studies of acute bacterial skin and skin structure infections (ABSSSIs) (REVIVE-1 and -2). Seven hundred ninety baseline isolates, including Staphylococcus aureus, β-hemolytic streptococci, and Streptococcus anginosus group, underwent antibacterial susceptibility testing. Iclaprim had an MIC90 of 0.12 μg/ml for S. aureus (0.12 μg/ml for methicillin susceptible, 0.25 μg/ml for methicillin resistant), 0.25 μg/ml for β-hemolytic streptococci, and 0.008 μg/ml for S. anginosus group. Iclaprim demonstrated potent activity against these Gram-positive ABSSSI isolates.

scholarly journals In Vitro Antimicrobial Susceptibility Testing of Helicobacter felis, H. bizzozeronii, and H. salomonis

2005 ◽  
Vol 49 (7) ◽  
pp. 2997-3000 ◽  
Author(s):  
K. Van den Bulck ◽  
A. Decostere ◽  
I. Gruntar ◽  
M. Baele ◽  
B. Krt ◽  
...  
Keyword(s):  
Antimicrobial Agent ◽  
Antimicrobial Agents ◽  
Susceptibility Testing ◽  
Acquired Resistance ◽  
Dilution Method ◽  
Agar Dilution Method ◽  
Helicobacter Felis ◽  
Agar Dilution

ABSTRACT The susceptibilities of Helicobacter felis (15 strains), H. bizzozeronii (7 strains), and H. salomonis (3 strains) to 10 antimicrobial agents were investigated by determination of the MIC using the agar dilution method. No consistent differences were noticed between the different Helicobacter species, which were all highly susceptible to ampicillin, clarithromycin, tetracycline, tylosin, enrofloxacin, gentamicin, and neomycin, as demonstrated by low MICs. Higher MICs were obtained for lincomycin (up to 8 μg/ml) and spectinomycin (up to 4 μg/ml). Two H. felis strains showed a MIC of 16 μg/ml for metronidazole, suggesting acquired resistance to this antimicrobial agent.

scholarly journals Multicenter Comparison of the Etest and EUCAST Methods for Antifungal Susceptibility Testing of Candida Isolates to Micafungin

2016 ◽  
Vol 60 (8) ◽  
pp. 5088-5091 ◽  
Author(s):  
M.-E. Bougnoux ◽  
E. Dannaoui ◽  
I. Accoceberry ◽  
A. Angoulvant ◽  
E. Bailly ◽  
...  
Keyword(s):  
Susceptibility Testing ◽  
Antifungal Susceptibility ◽  
Reference Method ◽  
Antifungal Susceptibility Testing ◽  
Medical Mycology ◽  
Single Center ◽  
Content Type ◽  
Valuable Alternative

ABSTRACTIn vitrosusceptibility of 933Candidaisolates, from 16 French hospitals, to micafungin was determined using the Etest in each center. All isolates were then sent to a single center for determination of MICs by the EUCAST reference method. Overall essential agreement between the two tests was 98.5% at ±2 log2dilutions and 90.2% at ±1 log2dilutions. Categorical agreement was 98.2%. The Etest is a valuable alternative to EUCAST for the routine determination of micafungin MICs in medical mycology laboratories.

scholarly journals HighIn VitroSusceptibility to the Novel Spiropyrimidinetrione ETX0914 (AZD0914) among 873 Contemporary Clinical Neisseria gonorrhoeae Isolates from 21 European Countries from 2012 to 2014

2015 ◽  
Vol 59 (9) ◽  
pp. 5220-5225 ◽  
Author(s):  
Magnus Unemo ◽  
Johan Ringlander ◽  
Catherine Wiggins ◽  
Hans Fredlund ◽  
Susanne Jacobsson ◽  
...  
Keyword(s):  
Neisseria Gonorrhoeae ◽  
European Countries ◽  
Cross Resistance ◽  
Dilution Method ◽  
Agar Dilution Method ◽  
The Novel ◽  
Content Type ◽  
Agar Dilution

ABSTRACTResistance inNeisseria gonorrhoeaeagainst all antimicrobials available for the treatment of gonorrhea has emerged. The first gonococcal strains with high-level resistance to ceftriaxone, the last option for first-line empirical antimicrobial monotherapy, were recently described. Consequently, new treatment options are essential. In this study, thein vitroactivity of the novel spiropyrimidinetrione ETX0914 (AZD0914), a DNA topoisomerase II inhibitor, was investigated among contemporary consecutive clinicalN. gonorrhoeaeisolates obtained in 21 European countries and compared to the activities of antimicrobials currently or previously recommended for treatment. Consecutive clinicalN. gonorrhoeaeisolates (n= 873) cultured in 21 European countries from 2012 to 2014 were examined for their susceptibility to ETX0914. The MICs of ETX0914 were determined using the agar dilution method. For comparison, the MICs of ceftriaxone, cefixime, azithromycin, and ciprofloxacin were determined using Etest or the agar dilution method. For ETX0914, the MIC range, modal MIC, MIC50, and MIC90were ≤0.002 to 0.25 mg/liter, 0.125 mg/liter, 0.064 mg/liter, and 0.125 mg/liter, respectively. The MIC values were substantially lower than those of the fluoroquinolone ciprofloxacin and most other antimicrobials examined. No cross-resistance with any other examined antimicrobial was observed. In conclusion, thein vitrosusceptibility to the novel spiropyrimidinetrione ETX0914 (AZD0914) among 873 contemporary clinical isolates from 21 European countries was high, and no cross-resistance to antimicrobials currently or previously used for gonorrhea treatment was indicated. Additional studies investigating thein vitroandin vivoinduction and mechanisms of ETX0914 resistance in gonococci, pharmacokinetics/pharmacodynamics in modeling/simulations and in humans, and performance in randomized controlled gonorrhea treatment trials are essential.

scholarly journals A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing

2016 ◽  
Vol 54 (12) ◽  
pp. 2956-2962 ◽  
Author(s):  
Koné Kaniga ◽  
Daniela M. Cirillo ◽  
Sven Hoffner ◽  
Nazir A. Ismail ◽  
Devinder Kaur ◽  
...  
Keyword(s):  
Quality Control ◽  
Reference Strain ◽  
Susceptibility Testing ◽  
Geometric Mean ◽  
Drug Susceptibility ◽  
Drug Susceptibility Testing ◽  
Broth Microdilution ◽  
Data Set ◽  
Content Type ◽  
Agar Dilution

The aim of this study was to establish standardized drug susceptibility testing (DST) methodologies and reference MIC quality control (QC) ranges for bedaquiline, a diarylquinoline antimycobacterial, used in the treatment of adults with multidrug-resistant tuberculosis. Two tier-2 QC reproducibility studies of bedaquiline DST were conducted in eight laboratories using Clinical Laboratory and Standards Institute (CLSI) guidelines. Agar dilution and broth microdilution methods were evaluated.Mycobacterium tuberculosisH37Rv was used as the QC reference strain. Bedaquiline MIC frequency, mode, and geometric mean were calculated. When resulting data occurred outside predefined CLSI criteria, the entire laboratory data set was excluded. For the agar dilution MIC, a 4-dilution QC range (0.015 to 0.12 μg/ml) centered around the geometric mean included 95.8% (7H10 agar dilution; 204/213 observations with one data set excluded) or 95.9% (7H11 agar dilution; 232/242) of bedaquiline MICs. For the 7H9 broth microdilution MIC, a 3-dilution QC range (0.015 to 0.06 μg/ml) centered around the mode included 98.1% (207/211, with one data set excluded) of bedaquiline MICs. Microbiological equivalence was demonstrated for bedaquiline MICs determined using 7H10 agar and 7H11 agar but not for bedaquiline MICs determined using 7H9 broth and 7H10 agar or 7H9 broth and 7H11 agar. Bedaquiline DST methodologies and MIC QC ranges against the H37RvM. tuberculosisreference strain have been established: 0.015 to 0.12 μg/ml for the 7H10 and 7H11 agar dilution MICs and 0.015 to 0.06 μg/ml for the 7H9 broth microdilution MIC. These methodologies and QC ranges will be submitted to CLSI and EUCAST to inform future research and provide guidance for routine clinical bedaquiline DST in laboratories worldwide.

scholarly journals DelafloxacinIn VitroBroth Microdilution and Disk Diffusion Antimicrobial Susceptibility Testing Guidelines: Susceptibility Breakpoint Criteria and Quality Control Ranges for an Expanded-Spectrum Anionic Fluoroquinolone

2018 ◽  
Vol 56 (8) ◽  
Author(s):  
M. A. Pfaller ◽  
R. K. Flamm ◽  
S. P. McCurdy ◽  
C. M. Pillar ◽  
D. Shortridge ◽  
...  
Keyword(s):  
Quality Control ◽  
Susceptibility Testing ◽  
Test Methods ◽  
Susceptibility Test ◽  
Disk Diffusion ◽  
Surveillance Program ◽  
Broth Microdilution ◽  
Testing Methods ◽  
Content Type

ABSTRACTDelafloxacin, a recently approved anionic fluoroquinolone, was tested within an international resistance surveillance program. Thein vitrosusceptibilities of 7,914 indicated pathogens causing acute bacterial skin and skin structure infections (ABSSSI) were determined using Clinical and Laboratory Standards Institute (CLSI) broth microdilution MIC testing methods. The U.S. Food and Drug Administration (FDA) susceptibility testing breakpoints and quality control ranges for routine broth microdilution and disk diffusion methods were confirmed. The delafloxacin MIC50/90(% susceptibility) results were as follows:Staphylococcus aureus, including methicillin-resistantS. aureus(MRSA), 0.008/0.25 μg/ml (92.8%);Staphylococcus lugdunensis, 0.016/0.03 μg/ml (99.3%);Streptococcus pyogenes, 0.016/0.03 μg/ml (100.0%);Streptococcus anginosusgroup, 0.008/0.016 μg/ml (100.0%);Enterococcus faecalis, 0.12/1 μg/ml (66.2%); andEnterobacteriaceae, 0.12/4 μg/ml (69.5%). The FDA clinical breakpoints were used to assess intermethod test agreement between delafloxacin MIC and disk diffusion methods for the indicated pathogens. The intermethod susceptibility test categorical agreement for delafloxacin was acceptable, with only 0.4% very major, false-susceptible errors amongS. aureusstrains. Across all FDA-indicated species, the selected breakpoints produced only 0.0 to 1.7% rates of serious (very major and major errors) intermethod error. Quality control ranges for these standardized delafloxacin susceptibility test methods were calculated from three multilaboratory (12 total sites) studies for six control organisms. In conclusion, the application of FDA MIC breakpoints for delafloxacin against contemporary (2014 to 2016) isolates of ABSSSI pathogens provides additional support for the use of delafloxacin in the treatment of adults with ABSSSI. Delafloxacin MIC and disk diffusion susceptibility testing methods have been standardized for clinical application, achieving high intermethod categorical agreement.

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