Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.

Publication Type
Journal Article
Year of Publication
2020
Authors
Klausner, Jeffrey D; Bristow, Claire C; Soge, Olusegun O; Shahkolahi, Akbar; Waymer, Toni; Bolan, Robert K; Philip, Susan S; Asbel, Lenore E; Taylor, Stephanie N; Mena, Leandro A; Goldstein, Deborah A; Powell, Jonathan A; Wierzbicki, Michael R; Morris, Sheldon R
Secondary
Clin Infect Dis
Date Published
2020 Aug 07
Keywords
antimicrobial resistance; ciprofloxacin; gyrase A gene; Neisser ia gonorrhoeae; serine 91
Abstract

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.