Rationale for a Neisseria gonorrhoeae Susceptible Only Interpretive Breakpoint for Azithromycin

Details

• Alternative Title:
  Clin Infect Dis
• Personal Author:
  Kersh, Ellen N. ; Allen, Vanessa ; Ransom, Eric ; Schmerer, Matthew ; St. Cyr, Sancta ; Workowski, Kim ; Weinstock, Hillard ; Patel, Jean ; Ferraro, Mary Jane
• Description:
  BACKGROUND:
  
  Azithromycin (AZI) is recommended with Ceftriaxone (CRO) for treatment of uncomplicated gonococcal urethritis and cervicitis in the United States (US) and an AZI susceptibility breakpoint is needed. Neither the FDA (Food and Drug Administration) nor the CLSI (Clinical and Laboratory Standards Institute) 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 over 550,000 US gonorrhea cases reported to the CDC in 2017, the highest number of cases since 1991.
  
  METHODS:
  
  This document summarizes the rationale data reviewed by the CLSI in June 2018.
  
  RESULTS:
  
  CLSI decided to set a susceptible only interpretive breakpoint at the MIC (Minimum Inhibitory Concentration) of and below 1 μg/ml. This is also the epidemiological cut-off value (ECV), i.e., the end of the wild-type susceptibility distribution. This breakpoint presumes that AZI (1 gm single dose) is used in an approved regimen that includes an additional antimicrobial agent (i.e. CRO 250 mg, intramuscular [IM] single dose).
  
  CONCLUSION:
  
  Having 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 EUCAST (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.
  
  
• Subjects:
  Antimicrobial Resistance Article Breakpoints Interpretive Criteria Neisseria Gonorrhoeae
• Source:
  Clin Infect Dis.
• Pubmed ID:
  30963175
• Pubmed Central ID:
  PMC6785360
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHS/United States
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:05f818dd1da016fc57abc16b7795b7cf4271a6fef790e77adddde4d53723275c
• Download URL:
  https://stacks.cdc.gov/view/cdc/95036/cdc_95036_DS1.pdf
• File Type:
  [PDF - 196.72 KB ]