Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.
Neisseria gonorrhoeae
antimicrobial resistance
ciprofloxacin
gyrase A gene
serine 91
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:
15 07 2021
15 07 2021
Historique:
received:
10
01
2020
accepted:
14
05
2020
pubmed:
9
8
2020
medline:
5
8
2021
entrez:
9
8
2020
Statut:
ppublish
Résumé
Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections. Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment. Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%). Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible. NCT02961751.
Sections du résumé
BACKGROUND
Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections.
METHODS
Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment.
RESULTS
Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%).
CONCLUSIONS
Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible.
CLINICAL TRIALS REGISTRATION
NCT02961751.
Identifiants
pubmed: 32766725
pii: 5882191
doi: 10.1093/cid/ciaa596
pmc: PMC8282307
doi:
Substances chimiques
Anti-Bacterial Agents
0
Ciprofloxacin
5E8K9I0O4U
Banques de données
ClinicalTrials.gov
['NCT02961751']
Types de publication
Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
298-303Subventions
Organisme : NIAID NIH HHS
ID : K01 AI136725
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI036214
Pays : United States
Organisme : NIAID NIH HHS
ID : HHSN272201300014I
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : ErratumIn
Informations de copyright
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
Références
Sex Transm Dis. 2020 Feb;47(2):111-113
pubmed: 31688726
Sex Health. 2019 Sep;16(5):412-425
pubmed: 31437420
J Infect Dis. 2017 Nov 27;216(9):1141-1149
pubmed: 28968710
JAMA. 2013 May 15;309(19):1989
pubmed: 23677303
Sex Transm Dis. 2018 Apr;45(4):e18
pubmed: 29465685
J Microbiol Methods. 2018 Sep;152:154-164
pubmed: 30063958
JAMA. 2015 Nov 3;314(17):1869-71
pubmed: 26529166
JAMA. 2019 Apr 9;321(14):1380-1390
pubmed: 30964528
J Antimicrob Chemother. 2019 Jul 1;74(7):1820-1824
pubmed: 30897201
JAMA. 2013 Jan 9;309(2):163-70
pubmed: 23299608
N Engl J Med. 2010 Sep 9;363(11):1005-15
pubmed: 20825313
N Engl J Med. 1991 Feb 7;324(6):384-94
pubmed: 1987461
N Engl J Med. 2005 Feb 17;352(7):676-85
pubmed: 15716561
Lancet Infect Dis. 2018 Jul;18(7):717-718
pubmed: 29976521
Antimicrob Agents Chemother. 2017 Dec 21;62(1):
pubmed: 29038267
J Antimicrob Chemother. 2015 Feb;70(2):374-81
pubmed: 25331059
Clin Infect Dis. 2017 May 1;64(9):1268-1270
pubmed: 28034887
Am J Public Health. 2003 Jun;93(6):882-4
pubmed: 12773344
MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137
pubmed: 26042815
Diagn Microbiol Infect Dis. 2019 Jul;94(3):213-217
pubmed: 30723007
J Clin Microbiol. 2007 Apr;45(4):1250-4
pubmed: 17267635
MMWR Morb Mortal Wkly Rep. 2007 Apr 13;56(14):332-6
pubmed: 17431378
Nat Rev Urol. 2019 Sep;16(9):509-510
pubmed: 31182853
Sex Transm Dis. 2017 May;44(5):261-265
pubmed: 28407640
PLoS Pathog. 2016 May 19;12(5):e1005611
pubmed: 27196299