Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study
Jeffrey D Klausner, Claire C Bristow, Olusegun O Soge, Akbar Shahkolahi, Toni Waymer, Robert K Bolan, Susan S Philip, Lenore E Asbel, Stephanie N Taylor, Leandro A Mena, Deborah A Goldstein, Jonathan A Powell, Michael R Wierzbicki, Sheldon R Morris, Jeffrey D Klausner, Claire C Bristow, Olusegun O Soge, Akbar Shahkolahi, Toni Waymer, Robert K Bolan, Susan S Philip, Lenore E Asbel, Stephanie N Taylor, Leandro A Mena, Deborah A Goldstein, Jonathan A Powell, Michael R Wierzbicki, Sheldon R Morris
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.
Keywords: Neisseria gonorrhoeae; antimicrobial resistance; ciprofloxacin; gyrase A gene; serine 91.
© 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.
Source: PubMed