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

2020 Aug 07

Journal Article

Klausner, J.D.; Bristow, C.C.; Soge, O.O.; Shahkolahi, A.; Waymer, T.; Bolan, R.K.; Philip, S.S.; Asbel, L.E.; Taylor, S.N.; Mena, L.A.; Goldstein, D.A.; Powell, J.A.; Wierzbicki, M.R.; Morris, S.R.

Clin Infect Dis




antimicrobial resistance; ciprofloxacin; gyrase A gene; Neisser ia gonorrhoeae; serine 91

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.

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