Dataset Information

Sulopenem Disk Development, Quality Control Range, and MIC to Disk Result Correlation for Enterobacterales Isolates.

ABSTRACT: Sulopenem disk masses of 2, 5, 10, and 20 μg were evaluated by susceptibility testing isolates by broth microdilution and disk diffusion. A 2-μg disk was chosen, and error-rate bounding analysis in accordance with Clinical and Laboratory Standards Institute (CLSI) guideline M23 was conducted using a proposed sulopenem susceptible/intermediate/resistant (S/I/R) interpretive criterion of ≤0.5/1/≥2 μg/mL. Among the evaluated Enterobacterales (n = 2,856), very few interpretive errors were observed (no very major errors and only one major error). An eight-laboratory quality control (QC) study was performed using the 2-μg disk, and 99.0% (470/475) of results were within a 7-mm range of 24 to 30 mm. Results were similar by disk lot and media, and no outlier sites were observed. A sulopenem 2-μg disk QC range for Escherichia coli 29522 of 24 to 30 mm was established by the CLSI. A 2-μg sulopenem disk performs accurately and reproducibly for testing of Enterobacterales.

SUBMITTER: Puttagunta S

PROVIDER: S-EPMC10358168 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Sulopenem Disk Development, Quality Control Range, and MIC to Disk Result Correlation for Enterobacterales Isolates.

Puttagunta Sailaja S Aronin Steven I SI DiFranco-Fisher Jeanna J Koeth Laura L

Journal of clinical microbiology 20230626 7

Sulopenem disk masses of 2, 5, 10, and 20 μg were evaluated by susceptibility testing isolates by broth microdilution and disk diffusion. A 2-μg disk was chosen, and error-rate bounding analysis in accordance with Clinical and Laboratory Standards Institute (CLSI) guideline M23 was conducted using a proposed sulopenem susceptible/intermediate/resistant (S/I/R) interpretive criterion of ≤0.5/1/≥2 μg/mL. Among the evaluated Enterobacterales (n = 2,856), very few interpretive errors w ...[more]

PMID: 37358462

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Project description:ObjectivesPhysicians must leverage several factors when making antibiotic therapy decisions, including route of administration and duration of therapy. Oral administration provides several potential advantages including increased accessibility, prevention of hospitalizations and earlier discharges. Sulopenem-a broad-spectrum, synthetic penem β-lactam agent-uniquely possesses both oral and IV formulations along with noted stability among antimicrobial-resistant subsets. This study evaluated the in vitro activity of sulopenem and comparator agents against contemporary Enterobacterales and anaerobic clinical isolates predominantly from patients with bloodstream, intra-abdominal and urinary tract infections.MethodsA contemporary collection of 1647 Enterobacterales and 559 anaerobic isolates was assembled from medical centres in Europe and the USA. Isolates were susceptibility tested using the CLSI reference methods: broth microdilution for Enterobacterales and agar dilution for anaerobes.ResultsSulopenem demonstrated potent in vitro antimicrobial activity (MIC50/90, 0.03/0.25 mg/L) against Enterobacterales isolates regardless of infection type, inhibiting 99.2% of isolates at ≤1 mg/L. This activity was conserved against resistant phenotypes including ESBL-phenotype Escherichia coli (MIC50/90, 0.03/0.06 mg/L) and ESBL-phenotype Klebsiella pneumoniae (MIC50/90, 0.06/1 mg/L). Sulopenem maintained activity against ciprofloxacin-, nitrofurantoin- and trimethoprim/sulfamethoxazole-non-susceptible subsets (MIC50/90, 0.03-0.06/0.12-0.5 mg/L). Against anaerobic isolates, sulopenem (98.9% inhibited at ≤4 mg/L) and meropenem [98.4% susceptible (CLSI)] were the most active compounds tested.ConclusionsThe potent in vitro activity of sulopenem against this large collection of recent Enterobacterales and anaerobic clinical isolates from multiple infection types supports its further clinical evaluation in the treatment of intra-abdominal and urinary tract infections.

Dataset Information

Sulopenem Disk Development, Quality Control Range, and MIC to Disk Result Correlation for Enterobacterales Isolates.

Publications

Sulopenem Disk Development, Quality Control Range, and MIC to Disk Result Correlation for <i>Enterobacterales</i> Isolates.

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