ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020
Rationale for a Neisseria gonorrhoeae Susceptible-only Interpretive Breakpoint for Azithromycin.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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17 citing papers in PubMed, 28 citations in OpenAlex.
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- The Distribution and Spread of Susceptible and Resistant Neisseria gonorrhoeae Across Demographic Groups in a Major Metropolitan Center.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- A community-driven resource for genomic epidemiology and antimicrobial resistance prediction of Neisseria gonorrhoeae at Pathogenwatch.Genome medicine · 2021Article
- Update to CDC's Treatment Guidelines for Gonococcal Infection, 2020.MMWR. Morbidity and mortality weekly report · 2020Article
- Sudden emergence of aMicrobial genomics · 2020Article
- Increased power from conditional bacterial genome-wide association identifies macrolide resistance mutations in Neisseria gonorrhoeae.Nature communications · 2020Article
- Testing ofJournal of clinical microbiology · 2020Article
- Adaptation to the cervical environment is associated with increased antibiotic susceptibility in Neisseria gonorrhoeae.Nature communications · 2020Article
- Azithromycin susceptibility ofThe Lancet. Microbe · 2020Article
- Article
- Expanding U.S. Laboratory Capacity for Neisseria gonorrhoeae Antimicrobial Susceptibility Testing and Whole-Genome Sequencing through the CDC's Antibiotic Resistance Laboratory Network.Journal of clinical microbiology · 2020Review
- Rapid inference of antibiotic resistance and susceptibility by genomic neighbour typing.Nature microbiology · 2020Article
- Variability in Azithromycin Susceptibility Results for Neisseria gonorrhoeae Obtained Using Gradient MIC Strip and Agar Dilution Techniques.Journal of clinical microbiology · 2019Article
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Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundAzithromycin (AZI) is recommended with ceftriaxone (CRO) for treatment of uncomplicated gonococcal urethritis and cervicitis in the United States, and an AZI-susceptibility breakpoint is needed. Neither the Food and Drug Administration (FDA) nor the Clinical and Laboratory Standards Institute (CLSI) has set interpretive breakpoints for AZI susceptibility. As a result, AZI antimicrobial susceptibility testing (AST) cannot be interpreted using recognized standards. This has contributed to increasingly unavailable clinical laboratory AST, although gonorrhea is on the rise with >550 000 US gonorrhea cases reported to the Centers for Disease Control and Prevention in 2017, the highest number of cases since 1991.
methodsThis article summarizes the rationale data reviewed by the CLSI in June 2018.
resultsThe CLSI decided to set a susceptible-only interpretive breakpoint at the minimum inhibitory concentration of ≤1 µg/mL. This is also the epidemiological cutoff value (ECV) (ie, the end of the wild-type susceptibility distribution). This breakpoint presumes that AZI (1-g single dose) is used in an approved regimen that includes an additional antimicrobial agent (ie, CRO 250 mg, intramuscular single dose).
conclusionsHaving a breakpoint can improve patient care and surveillance and allow future development and FDA regulatory approval of modernized AST to guide treatment. The breakpoint coincides with a European Committee on AST decision to remove previously established, differing AZI breakpoints and use the ECV as guidance for testing. The CLSI breakpoint is now the recognized standard that defines AZI susceptibility for gonococcal infections.
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