Clinical Trial

. 2021 Jul 15;73(2):298-303.

doi: 10.1093/cid/ciaa596.

Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study

Affiliations

¹ Departments of Medicine and Epidemiology, University of California, Los Angeles, Los Angeles, California, USA.
² Department of Medicine, University of California, San Diego, La Jolla, California, USA.
³ Neisseria Reference Laboratory, University of Washington, Seattle, Washington, USA.
⁴ Social Scientific Systems, Silver Spring, Maryland, USA.
⁵ Los Angeles LGBT Center, Los Angeles, California, USA.
⁶ San Francisco Department of Public Health, San Francisco, California, USA.
⁷ Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA.
⁸ Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
⁹ University of Mississippi Medical Center, Oxford, Mississippi, USA.
¹⁰ Whitman Walker Health, Washington, D.C., USA.
¹¹ The Emmes Company, Rockville, Maryland, USA.

PMID: 32766725
PMCID: PMC8282307
DOI: 10.1093/cid/ciaa596

Clinical Trial

Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study

Jeffrey D Klausner et al. Clin Infect Dis. 2021.

. 2021 Jul 15;73(2):298-303.

doi: 10.1093/cid/ciaa596.

Authors

Affiliations

¹ Departments of Medicine and Epidemiology, University of California, Los Angeles, Los Angeles, California, USA.
² Department of Medicine, University of California, San Diego, La Jolla, California, USA.
³ Neisseria Reference Laboratory, University of Washington, Seattle, Washington, USA.
⁴ Social Scientific Systems, Silver Spring, Maryland, USA.
⁵ Los Angeles LGBT Center, Los Angeles, California, USA.
⁶ San Francisco Department of Public Health, San Francisco, California, USA.
⁷ Philadelphia Department of Public Health, Philadelphia, Pennsylvania, USA.
⁸ Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
⁹ University of Mississippi Medical Center, Oxford, Mississippi, USA.
¹⁰ Whitman Walker Health, Washington, D.C., USA.
¹¹ The Emmes Company, Rockville, Maryland, USA.

PMID: 32766725
PMCID: PMC8282307
DOI: 10.1093/cid/ciaa596

Erratum in

Erratum to: Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.
[No authors listed] [No authors listed] Clin Infect Dis. 2021 Mar 1;72(5):911. doi: 10.1093/cid/ciaa1379. Clin Infect Dis. 2021. PMID: 33289033 Free PMC article. No abstract available.

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.

PubMed Disclaimer

Comment in

Antimicrobial Resistance in Gonorrhea: Diagnostics to the Rescue.
Marks M, Harding-Esch E. Marks M, et al. Clin Infect Dis. 2021 Jul 15;73(2):304-305. doi: 10.1093/cid/ciaa591. Clin Infect Dis. 2021. PMID: 32766713 No abstract available.
Optimizations to keep gonorrhoea treatable and reduce antimicrobial resistance selection.
Unemo M. Unemo M. Nat Rev Urol. 2020 Nov;17(11):609-610. doi: 10.1038/s41585-020-00378-5. Nat Rev Urol. 2020. PMID: 32929254 No abstract available.

References

1. Kirkcaldy RD , Hook EW 3rd, Soge OO, et al. Trends in Neisseria gonorrhoeae susceptibility to cephalosporins in the United States, 2006–2014. JAMA 2015; 314:1869–71. - PMC - PubMed
1. Dong HV , Klausner JD. Neisseria gonorrhoeae resistance driven by antibiotic use. Nat Rev Urol 2019; 16:509–10. - PubMed
1. Unemo M , Lahra MM, Cole M, et al. World Health Organization Global Gonococcal Antimicrobial Surveillance Program (WHO GASP): review of new data and evidence to inform international collaborative actions and research efforts. Sex Health 2019; 16:412–25. - PMC - PubMed
1. Whiley DM , Jennison A, Pearson J, Lahra MM. Genetic characterisation of Neisseria gonorrhoeae resistant to both ceftriaxone and azithromycin. Lancet Infect Dis 2018; 18:717–8. - PubMed
1. Allen VG , Mitterni L, Seah C, et al. Neisseria gonorrhoeae treatment failure and susceptibility to cefixime in Toronto, Canada. JAMA 2013; 309:163–70. - PubMed

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Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study

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Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study

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