Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study

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.

Automated summary

The study demonstrates that guided by resistance, treatment of N. gonorrhoeae infections with ciprofloxacin is highly effective, with a 100% efficacy rate in the per-protocol population. The widespread introduction and scale-up of genotyping of the gyrA serine 91 genotype in N. gonorrhoeae infections could have significant medical and public health benefits in settings where the majority of gonococcal infections are susceptible to ciprofloxacin.