Rationale for a Neisseria gonorrhoeae Susceptible-only Interpretive Breakpoint for Azithromycin.
Neisseria gonorrhoeae
antimicrobial resistance
breakpoints
interpretive criteria
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
14 02 2020
14 02 2020
Historique:
received:
30
10
2018
accepted:
04
04
2019
pubmed:
10
4
2019
medline:
7
1
2021
entrez:
10
4
2019
Statut:
ppublish
Résumé
Azithromycin (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. This article summarizes the rationale data reviewed by the CLSI in June 2018. The 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). 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 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.
Sections du résumé
BACKGROUND
Azithromycin (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.
METHODS
This article summarizes the rationale data reviewed by the CLSI in June 2018.
RESULTS
The 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).
CONCLUSIONS
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 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.
Identifiants
pubmed: 30963175
pii: 5432326
doi: 10.1093/cid/ciz292
pmc: PMC6785360
mid: NIHMS1044802
doi:
Substances chimiques
Anti-Bacterial Agents
0
Azithromycin
83905-01-5
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
798-804Subventions
Organisme : Intramural CDC HHS
ID : CC999999
Pays : United States
Informations de copyright
Published by Oxford University Press for the Infectious Diseases Society of America 2019.
Références
J Clin Microbiol. 2009 Oct;47(10):3142-6
pubmed: 19692559
Sex Transm Dis. 2004 Feb;31(2):73-8
pubmed: 14743069
MMWR Surveill Summ. 2016 Jul 15;65(7):1-19
pubmed: 27414503
MMWR Morb Mortal Wkly Rep. 2018 Apr 27;67(16):473-476
pubmed: 29698384
Antimicrob Agents Chemother. 2007 Jan;51(1):103-9
pubmed: 17060516
MMWR Morb Mortal Wkly Rep. 2007 Apr 13;56(14):332-6
pubmed: 17431378
MMWR Recomm Rep. 2014 Mar 14;63(RR-02):1-19
pubmed: 24622331
Sex Transm Dis. 1994 Mar-Apr;21(2):107-11
pubmed: 9071422
Clin Infect Dis. 2015 Feb 15;60(4):557-63
pubmed: 25371490
Int J STD AIDS. 1996;7 Suppl 1:2-4
pubmed: 8652723
Sex Transm Dis. 2012 Nov;39(11):877-9
pubmed: 23064537
Lancet Infect Dis. 2017 Aug;17(8):e235-e279
pubmed: 28701272
J Antimicrob Chemother. 2009 Aug;64(2):353-8
pubmed: 19468025
J Antimicrob Chemother. 2015 May;70(5):1290-7
pubmed: 25637520
N Engl J Med. 2005 Feb 17;352(7):676-85
pubmed: 15716561
Sex Transm Infect. 2003 Feb;79(1):56-8
pubmed: 12576616
J Antimicrob Chemother. 2014 Nov;69(11):3116-8
pubmed: 24948703
J Antimicrob Chemother. 1990 Jan;25 Suppl A:49-60
pubmed: 2154438
Biopharm Drug Dispos. 1991 Oct;12(7):505-14
pubmed: 1657238
PLoS One. 2017 Mar 28;12(3):e0174372
pubmed: 28350806
J Antimicrob Chemother. 2016 Nov;71(11):3109-3116
pubmed: 27432597
Sex Transm Dis. 2015 May;42(5):279-80
pubmed: 25868141
Eur J Clin Microbiol Infect Dis. 1991 Oct;10(10):807-12
pubmed: 1662623
Lancet Infect Dis. 2014 Mar;14(3):220-6
pubmed: 24462211
Int J STD AIDS. 2004 Apr;15(4):240-2
pubmed: 15075017
Int J STD AIDS. 2005 Jan;16(1):84
pubmed: 15705283
Clin Infect Dis. 2015 Feb 15;60(4):564-5
pubmed: 25371492
Antimicrob Agents Chemother. 2010 Jan;54(1):426-39
pubmed: 19884370
N Engl J Med. 2018 Nov 8;379(19):1835-1845
pubmed: 30403954
MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137
pubmed: 26042815
Euro Surveill. 2011 Apr 07;16(14):
pubmed: 21492528
Antimicrob Agents Chemother. 2017 Dec 21;62(1):
pubmed: 29038284
J Antimicrob Chemother. 2014 Aug;69(8):2086-90
pubmed: 24777907
Sex Transm Infect. 2010 Nov;86(6):422-6
pubmed: 20940153
mBio. 2018 Sep 11;9(5):
pubmed: 30206175
N Engl J Med. 2016 Jun 23;374(25):2504-6
pubmed: 27332921
J Antimicrob Chemother. 1993 Jun;31 Suppl E:193-8
pubmed: 8396093
J Antimicrob Chemother. 1990 Jan;25 Suppl A:109-14
pubmed: 2154428
MMWR Morb Mortal Wkly Rep. 2012 Aug 10;61(31):590-4
pubmed: 22874837
J Antimicrob Chemother. 1990 Jan;25 Suppl A:73-82
pubmed: 2154441
J Antimicrob Chemother. 2003 Aug;52(2):145-8
pubmed: 12837738
J Infect Dis. 2016 Nov 15;214(10):1579-1587
pubmed: 27638945